U.S. Department of Agriculture Makes It Easier for American Farmers to Grow Food, Ease Burdens for American Families | site |
Expands Insurance Coverage for Double Cropping for 2023 to Support Food Production, Lower Costs for American Families
Information contained in U.S. Department of Agriculture (USDA) press release dated: July 12, 2022
Washington, July 12, 2022 - - Today, the Biden Administration announced additional steps it’s taking to support U.S. farmers in their work to stabilize food prices and feed Americans and the world amidst continuing challenges such as the COVID-19 pandemic, supply chain disruptions, and the invasion of Ukraine by Russia. The U.S. Department of Agriculture is reducing the economic risk of raising two crops on the same land in one year, making it easier for U.S. farmers to grow food in America, increase food supply, and lower food costs for American families. This action is part of ...
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USDA Makes It Easier for American Farmers to Grow Food, Ease Burdens for American Families
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USDA Announces Framework for Shoring Up the Food Supply Chain and Transforming the Food System to Be Fairer, More Competitive, More Resilient
USDA Announces Framework for Shoring Up the Food Supply Chain and Transforming the Food System to Be Fairer, More Competitive, More Resilient
USDA efforts to create more and better markets will benefit both producers and American consumers through fairer prices, as well as address longstanding issues intensified by pandemic
Information contained in U.S. Department of Agriculture (USDA) press release dated: June 1, 2022
Washington, June 1, 2022 - Today, the U.S. Department of Agriculture (USDA) is announcing details of a framework to transform the food system to benefit consumers, producers and rural communities by providing more options, increasing access, and creating new, more, and better markets for small and mid-size producers. Today’s announcement builds on lessons learned from the COVID-19 pandemic and supply chain disruptions caused by Russia’s war in Ukraine. This announcement also provides additional details on the June... -
FDA Launches New Dietary Supplement Education Initiative for Consumers, Educators, and Healthcare Professionals
U.S. Food and Drug Administration Launches New Dietary Supplement Education Initiative for Consumers, Educators, and Healthcare Professionals | site |
Information contained in U.S. Food and Drug Administration (FDA) press release dated: June 2, 2022
Today, the U.S. Food and Drug Administration launched a new initiative, Supplement Your Knowledge, to help educate, inform, and broaden consumer, educator and healthcare professional understanding of dietary supplements. More than half of all Americans take dietary supplements daily or on occasion. Today’s Supplement Your Knowledge resources will provide reliable information about the potential benefits and risks associated with dietary supplements, such as vitamins, minerals, and herbs, they may consume. “Dietary supplements can be valuable to your health but taking some supplements can also involve health risks. It’s important for consumers to have a comprehensive understandi... -
U.S. Food and Drug Administration Roundup - - - May 17, 2022
U.S. Food and Drug Administration Roundup: May 17, 2022 | site |
Information contained in U.S. Food and Drug Administration (FDA) press release dated: May 17, 2022
|
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:- Today, the FDA published the FDA Voices: “FDA Seeks to Engage Stakeholders on Key Considerations for a Drug Quality Management Maturity Program,” Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER) and Patrizia Cavazzoni, MD, Director of CDER. The FDA will hold a two-day workshop on May 24 and 25 for stakeholders to learn more about a quality management program and to engage with the agency. The workshop is hosted by the CDER’s Small Business and Industry Assistance and will include speakers and panelists from outside the FDA to discuss quality management maturity.
- On May 15, the FDA issued
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FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability
U.S. Food and Drug Administration Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability | site |
Information contained in U.S. Food and Drug Administration (FDA) press release dated: May 16, 2022 Today, the U.S. Food and Drug Administration is announcing a guidance that outlines increased flexibilities regarding importation of certain infant formula products to further increase the availability of infant formula across the country while protecting the health of infants. The agency is encouraging infant formula manufacturers worldwide to take advantage of these flexibilities. “The FDA is leaving no stone unturned to further increase the availability of infant formula. We are doing everything in our power as part of the all-of-government efforts to ensure there’s adequate product available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert M. Califf, M.D. ... -
FDA Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact Containers
U.S. Food and Drug Administration Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact Containers | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: August 5, 2021)
The following quote is attributed to Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition
“The FDA is committed to ensuring that food containers are safe for consumers. We are encouraging manufacturers and distributors to consult with us regarding the regulatory status of any manufacturing processes used to produce fluorinated polyethylene containers for use in contact with food.
We issued this letter out of an abundance of caution to remind industry that only certain fluorinated containers may be used in contact with food. It is important to note that there is no evidence of unlawful manufacturing... -
FDA Approves First Oral Blood Thinning Medication for Children
U.S. Food and Drug Administration Approves First Oral Blood Thinning Medication for Children | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: June 21, 2021) Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism. In addition, Pradaxa was approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days, and to preve... -
USDA to Invest 1 Billion Dollars to Purchase Healthy Food for Food Insecure Americans and Build Food Bank Capacity
U.S. Department of Agriculture to Invest $1 Billion to Purchase Healthy Food for Food Insecure Americans and Build Food Bank Capacity | site |
First Investment of the New ‘Build Back Better’ Initiative Will Serve as a Bridge from Pandemic Assistance to Food System Transformation
(Information contained in U.S. Department of Agriculture press release dated: June 4, 2021) Washington, June 4, 2021 - - The U.S. Department of Agriculture (USDA) today announced an investment of up to $1 billion, including $500 million in American Rescue Plan funding, in The Emergency Food Assistance Program (TEFAP) to support and expand the emergency food network so states, food banks and local organizations can reliably serve their communities. Building on lessons learned during the COVID-19 pandemic, USDA will enter into cooperative agreements with state, Tribal and local entities to more efficiently purchase food from local producers and invest ... -
U.S. Department of Agriculture Launches 2021 Feds Feed Families Nationwide Food Drive
U.S. Department of Agriculture Launches 2021 Feds Feed Families Nationwide Food Drive | site |
Website makes it easy to participate, measure donations, and share success stories
(Information contained in U.S. Department of Agriculture press release dated: June 1, 2021) Washington, June 1, 2021 - - The U.S. Department of Agriculture (USDA) today kicked off the 12th annual government-wide Feds Feed Families (FFF) campaign, which encourages employees from all federal departments and agencies to give in-kind contributions -- food, services, and time -- to food banks and pantries. This year’s campaign highlights a summer of giving in June through August, along with seasonal reminders to donate throughout the year. “Feeding the hungry is perhaps the most critical job we have,” said Agriculture Secretary Tom Vilsack. “As the lead agency for this federal-wide food drive, I encourage all federal employees across the country to participate ... -
USDA to Purchase 159.4 Million Dollars in Nutritious Consumer-Ready Seafood and More for Food Assistance Programs
U.S. Department of Agriculture to Purchase $159.4 Million in Nutritious Consumer-Ready Seafood and More for Food Assistance Programs | site |
(Information contained in U.S. Department of Agriculture press release dated: May 13, 2021) Washington, May 13, 2021 - - The U.S. Department of Agriculture (USDA) today announced it will purchase up to $159.4 million in domestically produced seafood, fruits, legumes, and nuts for distribution to a variety of domestic food assistance programs, including charitable institutions. These purchases are being made utilizing funds under the authority of Section 32 of the Agricultural Adjustment Act (Pub. L. 74-320), as amended (Section 32). This is one of many actions USDA is taking to address the disruptions in the food system supply chain and worsened food insecurity resulting from the COVID-19 pandemic. “The impacts of COVID-19 reverberated from our farms to our oceans,” said Agriculture Secretary Tom Vilsack. “U.S. fisher... -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021
U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 9, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- On Friday, the FDA issued an Emergency Use Authorization (EUA) to Cue Health Inc. for its over-the-counter at-home diagnostic test for COVID-19. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that can be used completely at home without a prescription by people with or without COVID-19 symptoms. It requires the use of a compatible smartphone and a downloadable app. The app provides testing instructions and works with the Cue Cartridge Reader (provided separately) and the Cue testing cartridge to perform the test. Results are available in about 20 minutes.
- On Friday the FDA issued
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FDA Coronavirus COVID-19 Update - - - March 5, 2021
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: March 5, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA sent letters to 25 firms that produce and issue “FDA registration certificates” to medical device companies (including manufacturers, distributors and sellers). In the letters, the FDA is requesting that firms cease producing and issuing such registration certificates. The registration certificates often have the look of an official government document and many display the FDA logo. The FDA does not issue any type of device establishment registration certificate. Registration and listing with FDA does not denote approval or clearance of the establishment or its devices. Some device manufacturers and distributors
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CDC has Updated its Food Safety Alert for a Listeria Outbreak linked to Queso Fresco made by El Abuelito Cheese Inc.
Centers for Disease Control and Prevention has Updated its Food Safety Alert for a Listeria Outbreak linked to Queso Fresco made by El Abuelito Cheese Inc. | site |
(Information contained in Centers for Disease Control and Prevention [CDC] press release dated: February 27, 2021
CDC has updated its food safety alert for a Listeria outbreak linked to queso fresco made by El Abuelito Cheese Inc.: https://www.cdc.gov/listeria/outbrea...-21/index.html
Key points:- CDC has learned that two other types of cheeses, quesillo and requeson, are made or packed by El Abuelito Cheese Inc. at the same facility as the recalled queso fresco. CDC is concerned that these cheeses could also be contaminated and could make people sick.
- CDC is advising people at higher risk for severe Listeria illness to not eat any brand of quesillo or requeson cheeses until we learn more. This is because quesillo and requeson cheeses made or packed by El Abuelito
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CDC Investigating Multistate E. coli Outbreak with Unknown Food Source
Centers for Disease Control and Prevention Investigating Multistate E. coli Outbreak with Unknown Food Source | site |
(Information contained in Centers for Disease Control and Prevention [CDC] press release dated: February 3, 2021)
A CDC Investigation Notice about a new multistate outbreak of E. coli O157: E. coli Outbreak with Unknown Food Source.
Key Points:- CDC and state and federal public health and regulatory officials are working to identify the food source of a newly identified multistate outbreak of coli O157:H7 infections.
- 16 illnesses have been reported from 5 states: Arkansas (6), New York (1), Oklahoma (5), Virginia (2), and Washington (2).
- Many of the illnesses have been severe. Among 12 people with information available, 9 have been hospitalized. Three people developed kidney failure. One death has been reported from Washington.
- The strain causing this outbreak has previously caused other illnesses linked
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Biden Administration Expands P-EBT to Benefit Millions of Low-Income and Food Insecure Children During Pandemic
Biden Administration Expands P-EBT to Benefit Millions of Low-Income and Food Insecure Children During Pandemic | site |
USDA Says SNAP Benefits Are Inadequate for Most Participants and Begins Process to Extend Emergency Allotments to States and Update Thrifty Food Plan Formula
(Information contained in U.S. Department of Agriculture [USDA] press release dated: January 22, 2021) Washington, Jan. 22, 2021 — The U.S. Department of Agriculture announced several efforts today to expand nutrition assistance to hard-hit families across the country due to the coronavirus pandemic. In support of President Biden’s call to action on hunger and with authorities provided by Congress, USDA is increasing the Pandemic-EBT benefit by approximately 15%, providing more money for low-income families and millions of children missing meals due to school closures. Separately, in response to this national emergency, USDA is looking at ways to increase...
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U.S. Department of Agriculture Makes It Easier for American Farmers to Grow Food, Ease Burdens for American Families | site |
Expands Insurance Coverage for Double Cropping for 2023 to Support Food Production, Lower Costs for American Families
Information contained in U.S. Department of Agriculture (USDA) press release dated: July 12, 2022 Washington, July 12, 2022 - - Today, the Biden Administration announced additional steps it’s taking to support U.S. farmers in their work to stabilize food prices and feed Americans and the world amidst continuing challenges such as the COVID-19 pandemic, supply chain disruptions, and the invasion of Ukraine by Russia. The U.S. Department of Agriculture is reducing the economic risk of raising two crops on the same land in one year, making it easier for U.S. farmers to grow food in America, increase food supply, and lower food costs for American families. This action is part of ...07-15-2022, 05:33 AM -
USDA Announces Framework for Shoring Up the Food Supply Chain and Transforming the Food System to Be Fairer, More Competitive, More Resilient
USDA efforts to create more and better markets will benefit both producers and American consumers through fairer prices, as well as address longstanding issues intensified by pandemic
Information contained in U.S. Department of Agriculture (USDA) press release dated: June 1, 2022
Washington, June 1, 2022 - Today, the U.S. Department of Agriculture (USDA) is announcing details of a framework to transform the food system to benefit consumers, producers and rural communities by providing more options, increasing access, and creating new, more, and better markets for small and mid-size producers. Today’s announcement builds on lessons learned from the COVID-19 pandemic and supply chain disruptions caused by Russia’s war in Ukraine. This announcement also provides additional details on the June...06-04-2022, 06:33 PM -
U.S. Food and Drug Administration Launches New Dietary Supplement Education Initiative for Consumers, Educators, and Healthcare Professionals | site |
Information contained in U.S. Food and Drug Administration (FDA) press release dated: June 2, 2022
Today, the U.S. Food and Drug Administration launched a new initiative, Supplement Your Knowledge, to help educate, inform, and broaden consumer, educator and healthcare professional understanding of dietary supplements. More than half of all Americans take dietary supplements daily or on occasion. Today’s Supplement Your Knowledge resources will provide reliable information about the potential benefits and risks associated with dietary supplements, such as vitamins, minerals, and herbs, they may consume. “Dietary supplements can be valuable to your health but taking some supplements can also involve health risks. It’s important for consumers to have a comprehensive understandi...06-03-2022, 04:17 PM -
U.S. Food and Drug Administration Roundup: May 17, 2022 | site |
Information contained in U.S. Food and Drug Administration (FDA) press release dated: May 17, 2022
|
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:- Today, the FDA published the FDA Voices: “FDA Seeks to Engage Stakeholders on Key Considerations for a Drug Quality Management Maturity Program,” Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER) and Patrizia Cavazzoni, MD, Director of CDER. The FDA will hold a two-day workshop on May 24 and 25 for stakeholders to learn more about a quality management program and to engage with the agency. The workshop is hosted by the CDER’s Small Business and Industry Assistance and will include speakers and panelists from outside the FDA to discuss quality management maturity.
- On May 15, the FDA issued
05-19-2022, 07:56 AM -
U.S. Food and Drug Administration Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability | site |
Information contained in U.S. Food and Drug Administration (FDA) press release dated: May 16, 2022 Today, the U.S. Food and Drug Administration is announcing a guidance that outlines increased flexibilities regarding importation of certain infant formula products to further increase the availability of infant formula across the country while protecting the health of infants. The agency is encouraging infant formula manufacturers worldwide to take advantage of these flexibilities. “The FDA is leaving no stone unturned to further increase the availability of infant formula. We are doing everything in our power as part of the all-of-government efforts to ensure there’s adequate product available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert M. Califf, M.D. ...05-17-2022, 06:28 AM -
U.S. Food and Drug Administration Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact Containers | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: August 5, 2021)
The following quote is attributed to Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition
“The FDA is committed to ensuring that food containers are safe for consumers. We are encouraging manufacturers and distributors to consult with us regarding the regulatory status of any manufacturing processes used to produce fluorinated polyethylene containers for use in contact with food.
We issued this letter out of an abundance of caution to remind industry that only certain fluorinated containers may be used in contact with food. It is important to note that there is no evidence of unlawful manufacturing...08-14-2021, 10:08 PM -
U.S. Food and Drug Administration Approves First Oral Blood Thinning Medication for Children | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: June 21, 2021) Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism. In addition, Pradaxa was approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days, and to preve...06-22-2021, 04:08 AM -
U.S. Department of Agriculture to Invest $1 Billion to Purchase Healthy Food for Food Insecure Americans and Build Food Bank Capacity | site |
First Investment of the New ‘Build Back Better’ Initiative Will Serve as a Bridge from Pandemic Assistance to Food System Transformation
(Information contained in U.S. Department of Agriculture press release dated: June 4, 2021) Washington, June 4, 2021 - - The U.S. Department of Agriculture (USDA) today announced an investment of up to $1 billion, including $500 million in American Rescue Plan funding, in The Emergency Food Assistance Program (TEFAP) to support and expand the emergency food network so states, food banks and local organizations can reliably serve their communities. Building on lessons learned during the COVID-19 pandemic, USDA will enter into cooperative agreements with state, Tribal and local entities to more efficiently purchase food from local producers and invest ...06-11-2021, 08:17 PM -
U.S. Department of Agriculture Launches 2021 Feds Feed Families Nationwide Food Drive | site |
Website makes it easy to participate, measure donations, and share success stories
(Information contained in U.S. Department of Agriculture press release dated: June 1, 2021) Washington, June 1, 2021 - - The U.S. Department of Agriculture (USDA) today kicked off the 12th annual government-wide Feds Feed Families (FFF) campaign, which encourages employees from all federal departments and agencies to give in-kind contributions -- food, services, and time -- to food banks and pantries. This year’s campaign highlights a summer of giving in June through August, along with seasonal reminders to donate throughout the year. “Feeding the hungry is perhaps the most critical job we have,” said Agriculture Secretary Tom Vilsack. “As the lead agency for this federal-wide food drive, I encourage all federal employees across the country to participate ...06-08-2021, 10:16 PM -
U.S. Department of Agriculture to Purchase $159.4 Million in Nutritious Consumer-Ready Seafood and More for Food Assistance Programs | site |
(Information contained in U.S. Department of Agriculture press release dated: May 13, 2021) Washington, May 13, 2021 - - The U.S. Department of Agriculture (USDA) today announced it will purchase up to $159.4 million in domestically produced seafood, fruits, legumes, and nuts for distribution to a variety of domestic food assistance programs, including charitable institutions. These purchases are being made utilizing funds under the authority of Section 32 of the Agricultural Adjustment Act (Pub. L. 74-320), as amended (Section 32). This is one of many actions USDA is taking to address the disruptions in the food system supply chain and worsened food insecurity resulting from the COVID-19 pandemic. “The impacts of COVID-19 reverberated from our farms to our oceans,” said Agriculture Secretary Tom Vilsack. “U.S. fisher...05-15-2021, 02:38 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 9, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- On Friday, the FDA issued an Emergency Use Authorization (EUA) to Cue Health Inc. for its over-the-counter at-home diagnostic test for COVID-19. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that can be used completely at home without a prescription by people with or without COVID-19 symptoms. It requires the use of a compatible smartphone and a downloadable app. The app provides testing instructions and works with the Cue Cartridge Reader (provided separately) and the Cue testing cartridge to perform the test. Results are available in about 20 minutes.
- On Friday the FDA issued
03-10-2021, 09:14 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: March 5, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA sent letters to 25 firms that produce and issue “FDA registration certificates” to medical device companies (including manufacturers, distributors and sellers). In the letters, the FDA is requesting that firms cease producing and issuing such registration certificates. The registration certificates often have the look of an official government document and many display the FDA logo. The FDA does not issue any type of device establishment registration certificate. Registration and listing with FDA does not denote approval or clearance of the establishment or its devices. Some device manufacturers and distributors
03-08-2021, 05:10 AM -
Centers for Disease Control and Prevention has Updated its Food Safety Alert for a Listeria Outbreak linked to Queso Fresco made by El Abuelito Cheese Inc. | site |
(Information contained in Centers for Disease Control and Prevention [CDC] press release dated: February 27, 2021
CDC has updated its food safety alert for a Listeria outbreak linked to queso fresco made by El Abuelito Cheese Inc.: https://www.cdc.gov/listeria/outbrea...-21/index.html
Key points:- CDC has learned that two other types of cheeses, quesillo and requeson, are made or packed by El Abuelito Cheese Inc. at the same facility as the recalled queso fresco. CDC is concerned that these cheeses could also be contaminated and could make people sick.
- CDC is advising people at higher risk for severe Listeria illness to not eat any brand of quesillo or requeson cheeses until we learn more. This is because quesillo and requeson cheeses made or packed by El Abuelito
03-01-2021, 11:40 PM -
Centers for Disease Control and Prevention Investigating Multistate E. coli Outbreak with Unknown Food Source | site |
(Information contained in Centers for Disease Control and Prevention [CDC] press release dated: February 3, 2021)
A CDC Investigation Notice about a new multistate outbreak of E. coli O157: E. coli Outbreak with Unknown Food Source.
Key Points:- CDC and state and federal public health and regulatory officials are working to identify the food source of a newly identified multistate outbreak of coli O157:H7 infections.
- 16 illnesses have been reported from 5 states: Arkansas (6), New York (1), Oklahoma (5), Virginia (2), and Washington (2).
- Many of the illnesses have been severe. Among 12 people with information available, 9 have been hospitalized. Three people developed kidney failure. One death has been reported from Washington.
- The strain causing this outbreak has previously caused other illnesses linked
02-05-2021, 07:10 AM -
Biden Administration Expands P-EBT to Benefit Millions of Low-Income and Food Insecure Children During Pandemic | site |
USDA Says SNAP Benefits Are Inadequate for Most Participants and Begins Process to Extend Emergency Allotments to States and Update Thrifty Food Plan Formula
(Information contained in U.S. Department of Agriculture [USDA] press release dated: January 22, 2021) Washington, Jan. 22, 2021 — The U.S. Department of Agriculture announced several efforts today to expand nutrition assistance to hard-hit families across the country due to the coronavirus pandemic. In support of President Biden’s call to action on hunger and with authorities provided by Congress, USDA is increasing the Pandemic-EBT benefit by approximately 15%, providing more money for low-income families and millions of children missing meals due to school closures. Separately, in response to this national emergency, USDA is looking at ways to increase...01-22-2021, 09:05 PM -
Excerpt of U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 22, 2021 | site |
(Excerpt of information contained in U.S. Food and Drug Administration [FDA] press release dated: January 22, 2021)- The FDA is reissuing the Emergency Use Authorizations (EUAs) for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there is an insufficient supply of new respirators resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. Among other things, the reissued EUAs for certain decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times. Based on the FDA’s review of real-world use of these systems and evidence from adverse events and scientific literature, including studies regarding N95 respirator failures from simula
01-22-2021, 07:41 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 19, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: January 19, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, to help protect consumers from methanol poisoning, the FDA issued a new guidance, “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19),” to notify drug manufacturers and compounders of FDA’s policy on certain testing procedures on all lots of alcohol and isopropyl alcohol prior to manufacturing to prevent methanol contamination or substitution in drugs. Methanol is not an acceptable ingredient for any drug product and should not be used due to its toxic effects.
- To accelerate the adoption of advanced and smart manufacturing
01-19-2021, 06:14 PM -
USDA Offers Additional Assistance for Certain Producers Through Coronavirus Food Assistance Program | site |
(Information contained in U.S. Department of Agriculture press release dated: January 15, 2021) (Washington, D.C., January 15, 2021) – U.S. Secretary of Agriculture Sonny Perdue announced the U.S. Department of Agriculture (USDA) will provide additional assistance through the Coronavirus Food Assistance Program (CFAP), expanding eligibility for some agricultural producers and commodities as well as updating payments to accurately compensate some producers who already applied for the program. Producers who are now eligible and those who need to modify existing applications due to these updates can contact USDA’s Farm Service Agency (FSA) between Jan. 19 and Feb. 26. Some of these changes are being made to align with the recently enacted Consolidated Appropriations Act of 2021 while others are discretionary changes being made in response...01-19-2021, 06:27 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 15, 2021 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 15, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA issued and immediately implemented a new guidance entitled, “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.” This guidance assists prospective applicants of abbreviated new drug applications (ANDAs) on ensuring participants are protected when resuming or initiating bioequivalence studies conducted to support the approval of an ANDA that has been disrupted during the COVID-19 public health emergency.
- On January 14, the FDA issued and immediately implemented a new guidance entitled, “Coagulation Systems for Measurement
01-16-2021, 11:15 PM -
U.S. Food and Drug Administration Releases Artificial Intelligence/Machine Learning Action Plan | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: January 12, 2021)
Today, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software. “This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD,” said Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH). “The plan outlines a holistic approach based on total product lifecycle oversight to further the enormous potential that these technologies have to improve patient care while delivering safe and effecti...01-12-2021, 01:54 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 5, 2021 | site |
(Information included in U.S. Food and Drug Administration [FDA] press release dated: January 5, 2021)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA posted a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) highlighting authorities that are intended to enhance the FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing the FDA’s visibility into drug supply chains.
The CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to:Expand the requirement for manufacturers of certain drugs to provide information on permanent discontinuances and interruptions in manufacturing that may lead to a meaningful disruption in supply to the FDA. Include...01-05-2021, 08:05 PM -
U.S. Department of Agriculture Announces Continuation of the Farmers to Families Food Box Program, Fifth Round of Food Purchases | site |
(Information contained in U.S. Department of Agriculture press release dated: January 4, 2021)
(Washington, D.C., January 4, 2021) - - U.S. Secretary of Agriculture Sonny Perdue announced the U.S. Department of Agriculture (USDA) will purchase an additional $1.5 billion worth of food for nationwide distribution through the Farmers to Families Food Box Program. In total, USDA has distributed more than 132 million food boxes in support of American farmers and families affected by the COVID-19 pandemic. “This new round of Farmers to Families Food Boxes will go a long way in helping American families access nutritious and healthy meals as we recover from the COVID-19 pandemic. Thanks to the President Trump’s leadership, we have helped tens of millions of families and countless farmers with this program,” said Secret...01-04-2021, 10:50 PM -
Federal Emergency Management Agency Reimburses nearly $7 Million to Massachusetts for COVID-19 Food Security Response | site |
(Information contained in Federal Emergency Management Agency [FEMA] press release dated: December 31, 2020)
Region 1 – The Federal Emergency Management Agency (FEMA) has awarded $6,993,801 to Massachusetts Emergency Management Agency (MEMA) to reimburse eligible expenses for the delivery of food boxes to hundreds of thousands of residents in response to food insecurity caused by the COVID-19 pandemic. MEMA, along with the assistance of the Salvation Army, and a network of food banks and food pantries throughout Massachusetts coordinated and distributed 275,808 food boxes to eligible participants. “We are pleased to provide this significant grant to the Commonwealth of Massachusetts to help manage the financial demands associated with providing food for its citizens needing assistance during COVID-19,” said Region...01-02-2021, 08:59 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 28, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 28, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- On Dec. 23, the FDA updated the Device Shortage List on our web page that lists Medical Device Shortages During the COVID-19 Public Health Emergency. Specifically, the FDA added the following device types in the testing supplies and equipment category: pipette tips (product codes LXG and PPM) and micro pipettes (product code JRC). The FDA also added clarifying notes and links to more resources in the “Additional Information” column, as well as adding clarity to the categories, such as grouping gloves under “Personal Protective Equipment – Gloves.” The device shortage list reflects the categories of
12-29-2020, 05:17 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 22, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 22, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA has posted translations of the Moderna COVID-19 Vaccine fact sheet for recipients and caregivers, and the fact sheet for healthcare providers in languages including: Arabic, Chinese, French, Spanish, Tagalog, and Vietnamese. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.
- The FDA recently approved three abbreviated new drug applications (ANDAs):
On Dec. 18, one ANDA for etomidate injection, indicated for the induction of general anesthesia. The most common side effects of etomidate injection are venous pain on injection and...12-24-2020, 01:30 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 21, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 21, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA has posted translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet for recipients and caregivers in languages including: Arabic, Burmese, Cherokee, Chinese (Simplified and Traditional), Chuukese, German, Haitian Creole, Hindi, Hmong, Korean, Mam, Polish, Portuguese, Russian, Spanish, Somali, Tagalog, Vietnamese, and Yiddish. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.
- Today, the agency updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures, and highlights on
12-22-2020, 02:03 AM -
U.S. Food and Drug Administration Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine | site |
FDA says "Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts"
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: December 18, 2020) Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in...12-21-2020, 11:15 AM -
U.S. Food and Drug Administration Statement on Vaccines and Related Biological Products Advisory Committee Meeting | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 17, 2020)
Statement From:
Commissioner of Food and Drugs - Food and Drug Administration
Stephen M. Hahn M.D.
Director - Center for Biologics Evaluation and Research (CBER)
Peter Marks M.D., PhD.
Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.
The FDA, an agency...12-18-2020, 08:00 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 17, 2020| site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 17, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, met to discuss a request for emergency use authorization (EUA) for a vaccine for COVID-19 prevention, submitted by ModernaTX, Inc. This meeting is an important step in the review process, providing an opportunity for outside experts to provide valuable advice and input for the agency to consider as part of its review. Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials.
- Also
12-18-2020, 07:24 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 16, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: December 16, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA issued a new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is an antigen test that detects fragments of proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample. It is authorized for use at home with self-collected samples in individuals age 15 years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset. The test is also for use with individuals aged four years or older who
12-17-2020, 07:14 PM -
U.S. Food and Drug Administration Authorizes Marketing of New Implant to Repair a Torn ACL | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 16, 2020) Today, the U.S. Food and Drug Administration granted marketing authorization—under the De Novo premarket review pathway—for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture. “Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon...12-16-2020, 09:06 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 | site |
Test is authorized for individuals two years of age or older, including those not showing symptoms
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 15, 2020)
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. “Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-c...12-16-2020, 12:34 AM -
Excerpts from U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 14, 2020 | site |
(The following are EXCERPTS from information contained in a U.S. Food and Drug Administration [FDA] press release: December 14, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Yesterday, the FDA posted the review memorandum outlining the basis of the agency’s decision to authorize the Pfizer-BioNTech COVID-19 Vaccine. To ensure all Americans can have trust and confidence in the carefulness of FDA’s review, we have made, and will continue to make, the vaccine review process as transparent as possible.
- On Dec. 11, the agency approved an abbreviated new drug application for midazolam injection, indicated for preoperative sedation/anxiolysis (anxiety)/amnesia; as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic
12-15-2020, 04:57 AM -
U.S. Food and Drug Administration Virtual Press Conference: First COVID-19 Vaccine - 12/12/2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] release: December 12, 2020)
U.S. Food and Drug Administration Virtual Press Conference: First COVID-19 Vaccine - 12/12/2020
(Conference begins at the 44 seconds time point)
Courtesy: U.S. Food and Drug Administration...12-12-2020, 06:18 PM -
U.S. Food and Drug Administration takes Key Action in Fight Against COVID-19 by Issuing Emergency Use Authorization for First COVID-19 Vaccine | site |
FDA says "Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts"
(Information contained in U.S. Food and Drug Administration [FDA] press release dated: December 11, 2020)
Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S. “The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling...12-12-2020, 02:25 AM -
U.S. Food and Drug Administration Statement on Vaccines and Related Biological Products Advisory Committee Meeting | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release statement: December 11, 2020)
December 11, 2020
Statement From:
Commissioner of Food and Drugs - Food and Drug Administration
Stephen M. Hahn M.D.
Director - Center for Biologics Evaluation and Research (CBER)
Peter Marks M.D., PhD. Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution....12-11-2020, 08:53 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System | site |
Test system is authorized for at-home sample collection with laboratory test processing
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 9, 2020) Today, the U.S. Food and Drug Administration authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal. This home sample collection kit can be purchased online or in ...12-10-2020, 01:25 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 4, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 4, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA issued a guidance, “Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency.” This guidance provides the FDA’s enforcement policy regarding certain requirements for mammography facilities and general considerations in response to common scenarios faced by mammography facilities as a result of the COVID-19 public health emergency.
- On Dec. 3, the agency issued an Emergency Use Authorization (EUA) for the Lumin LM3000 Bioburden Reduction UV System, the first ultraviolet-C (UV-C) light based bioburden reduction system for emergency use
12-05-2020, 12:02 AM -
U.S. Food and Drug Administration Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: December 1, 2020) Today, the U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. Ga 68 PSMA-11 is indicated for patients with suspected prostate cancer metastasis (when cancer cells spread from the place where they first formed to another part of the body) who are potentially curable by surgery or radiation therapy. Ga 68 PSMA-11 is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels. Ga 68 PSMA-11 is a radioactive diagnostic agent that is administered in the form of an intravenous injection. “Ga 68 PS...12-01-2020, 10:23 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators | site |
(Information contained in U.S. Food and Drug Administration press release: November 25, 2020)
Today, the U.S. Food and Drug Administration (FDA) issued guidance on the use of dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, by health care personnel when there is a limited supply of respirators during the COVID-19 public health emergency. The immediately-in-effect guidance provides the FDA’s thinking and recommendations regarding the use of bioburden reduction systems that use dry heat to reduce the bioburden, or amount of microorganisms present, on certain respirators for reuse by a single user. Bioburden reduction systems are intended to achieve a certain level in microbial reduction on a device; these are not decontamina...11-27-2020, 04:13 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 24, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: November 24, 2020)
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA today published Face Masks, Including Surgical Masks, and Respirators for COVID-19, a comprehensive new page on FDA.gov with answers to frequently asked questions about face masks, surgical masks, and respirators. The topics covered in this new page include:
- The basics on face masks, surgical masks, and respirators
- Using face masks, surgical masks, and respirators
- Shortages of face masks, surgical masks, and respirators during COVID-19
- The Emergency Use Authorizations for face masks, surgical masks, and respirators
- Manufacturing and importing face masks, surgical masks, and respirators during
11-24-2020, 11:42 PM - The FDA today published Face Masks, Including Surgical Masks, and Respirators for COVID-19, a comprehensive new page on FDA.gov with answers to frequently asked questions about face masks, surgical masks, and respirators. The topics covered in this new page include:
-
U.S. Food and Drug Administration Approves First Drug to Treat Rare Metabolic Disorder | site |
Approval is for primary hyperoxaluria type 1, which causes recurrent kidney stones and loss of kidney function
(Information contained in U.S. Food and Drug Administration [FDA] press release: November 23, 2020) Today, the U.S. Food and Drug Administration approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder. This approval is a cumulation of the work of experts and community members coordinated by the Oxalosis & Hyperoxaluria Foundation and the Kidney Health Initiative. “The approval of Oxlumo represents a great triumph of community involvement to address a rare disease. It is a result of input from patients, treating physicians, experts and sponsors at a patient-focused drug development meeting and through other collaborative efforts,” said Norman Stockbridge, M.D., Ph.D., director of the ...11-24-2020, 05:35 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 23, 2020 | site |
(Information contained in U.S. Food and Drug Administration [FDA] press release: November 23, 2020)
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:- On Nov. 20, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American
11-24-2020, 05:23 AM -
Federal Emergency Management Agency Announces $140 Million for Emergency Food and Shelter Program | site |
(Information included in Federal Emergency Management Agency [FEMA] press release: November 23, 2020) WASHINGTON -- FEMA has announced that $140 million will be available to communities across the county to assist with feeding and sheltering. Congress made $125 million available for Fiscal Year 2020, and this year, the Emergency Food and Shelter Program (EFSP) National Board is including an additional $15 million from funds that have not been used from prior grant years. FEMA awarded the $125 million to the National Board, which is now allocating the funds, combined with the additional $15 million, to qualifying jurisdictions (counties and cities). EFSP funds assist local organizations dedicated to feeding, sheltering, and providing critical resources to people with economic emergencies, including our nation's hungry and homeless populations. These fun...11-23-2020, 08:17 PM -
U.S. Department of Agriculture Shares Easy At-Home Advice for Handling Food Safely this Thanksgiving | site |
(Information contained in U.S. Department of Agriculture press release: November 23, 2020) (Washington, D.C., November 23, 2020) – This week, Americans will enjoy a delicious meal on Thanksgiving Day with family and friends – either in person or virtually. Taking the necessary steps toward safe food handling and sanitation will help protect you and your loved ones this year. To make sure your Thanksgiving meal is prepared safely, the U.S. Department of Agriculture (USDA) is offering food safety advice to reduce foodborne illness, including on Thanksgiving Day. “Our data shows that consumers can reduce their likelihood of foodborne illness by focusing on good hand hygiene and other food safety practices,” said Dr. Mindy Brashears, USDA’s Under Secretary for Food Safety. “As home chefs nationwide prepare their Thanksgiving meals, proper handwashi...11-23-2020, 06:26 PM -
U.S. Food and Drug Administration Expands Approval of Influenza Treatment to Post-Exposure Prevention | site |
(Information contained in U.S. Food and Drug Administration press release: November 23, 2020)
Today, the U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. Xofluza, previously available only in tablet form, is also now available as granules for mixing in water. Xofluza was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours. “This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra ...11-23-2020, 05:37 PM -
FDA Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |
(Information contained in U.S. Food and Drug Administration (FDA) press release: November 21, 2020)
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for di...11-23-2020, 03:00 AM -
Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 | site |
(Information contained in U.S Food and Drug Administration [FDA] press release: November 19, 2020)
November 19, 2020
Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo w...11-20-2020, 03:08 AM -
U.S. Food and Drug Administration Releases New Outbreak Investigation Table | site |
(November 18, 2020) - - On November 18, 2020 the U.S. Food and Drug Administration (FDA) published the following information:
FDA Releases New Outbreak Investigation Table
New tool will communicate outbreak investigations in early stages
November 18, 2020
Statement From:
Deputy Commissioner for Food Policy and Response - Food and Drug Administration
Frank Yiannas
The U.S. Food and Drug Administration is committed to transparency and keeping the public and stakeholders informed of our work upholding the safety of our food supply. As part of this continued commitment, today we are releasing a new tool to communicate foodborne illness outbreak information frequently and as soon as the FDA begins an outbreak investigation – prior to a public health advisory or recall of a certain...11-19-2020, 06:13 AM -
U.S. Food and Drug Administration COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs | site |
(November 17, 2020) - - Today the U.S. Food and Drug Administration (FDA) published the following information:
November 17, 2020
Statement From: Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Emergency use authorizations, or EUAs, are an important tool in our country’s fight against COVID-19 and other public health emergencies. While EUAs have received increased attention during the COVID-19 public health emergency, EUAs are not a new tool to the FDA. I want to take a moment to reaffirm FDA’s commitment to transparency around the EUA process and share some updates on our plan to provide more information about FDA’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines. Earlier this year, we launched the COVID-19 Pandemic Recovery and ...11-17-2020, 01:44 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 16, 2020 | site |
(November 16, 2020) - - The U.S. Food and Drug Administration (FDA) published (today) the following information:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, FDA updated its guidance on investigational COVID-19 convalescent plasma. The updated guidance extends the period of enforcement discretion through the end of February 2021. This extension will allow continued access to convalescent plasma for the treatment of hospitalized COVID-19 patients while blood establishments develop the necessary operating procedures to manufacture the plasma consistent with the EUA. The guidance also includes a new recommendation that authorized COVID-19 convalescent plasma not be collected from individuals who have received an investigational COVID-19 vaccine.
- The agency
11-17-2020, 01:24 PM -
FDA Encourages Manufacturers to Clearly Declare All Uses of Sesame in Ingredient List on Food LabelsU.S. Food and Drug Administration Encourages Manufacturers to Clearly Declare All Uses of Sesame in Ingredient List on Food Labels | site |
(November 10, 2020) - - On November 10, 2020 the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration today issued a draft guidance encouraging food manufacturers to voluntarily declare sesame in the ingredient list on food labels. “Many Americans are allergic or sensitive to sesame, and they need the ability to quickly identify products that might contain sesame,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “While most products containing sesame declare it as an ingredient, there are times when sesame is not required to be declared by name on the label, such as when it is used as a ‘flavor’ or ‘spice.’ Other ingredients, like ‘tahini,’ are made by grinding sesame into a past...11-16-2020, 12:56 AM -
USDA, EPA Welcome Two New Members as U.S. Food Loss and Waste 2030 Champions | site |
Meijer, UNFI commit to reduce food loss and waste in their operations
(November 12, 2020) - - The U.S. Department of Agriculture published (today) the following information:
(WASHINGTON, D.C., November 12, 2020) — Today, U.S. Department of Agriculture (USDA) Secretary Sonny Perdue and Environmental Protection Agency (EPA) Administrator Andrew Wheeler announced the addition of Meijer, an American supercenter chain throughout the Midwest, and UNFI, a North America Food wholesaler, to the U.S. Food Loss and Waste 2030 Champions. Champions are U.S. businesses and organizations that pledge to reduce food loss and waste in their own operations by 50 percent by the year 2030. The commitment and action of these businesses will help the U.S. move closer to the national goal, protect and save valuable resources, and improve food system efficiencies...11-12-2020, 12:44 PM -
U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - November 10, 2020 | site |
(November 10, 2020) - - On November 10, 2020 the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- On November 12, the FDA will host a virtual FDA Grand Rounds: Facial Coverings During the COVID-19 Pandemic: How well do they flatten the curve? This presentation provides an overview of the FDA’s research to evaluate the ability of facial coverings to reduce the spread of infection and how the FDA is developing a comprehensive risk-assessment tool to predict the probability of infection with individuals wearing a non-surgical face mask or cloth face covering; given the characteristics of non-surgical face masks, the population, and the pathogen. This presentation discusses how the
11-11-2020, 05:28 PM -
Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Authorizes Monoclonal Antibody for Treatment of COVID-19 | site |
(November 9, 2020) - - On November 9, 2020 the U.S. Food and Drug Administration (FDA) published the following information:
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivima...11-10-2020, 07:37 AM -
U.S. Food and Drug Administration Approves Lotion for Nonprescription Use to Treat Head Lice| site |
(October 27, 2020) - - The U.S. Food and Drug Administration (FDA) published today, October 27, 2020, the following information:
Today, the U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012.
“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” said Theresa Michele, M.D., acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research. “Today’s approval expands access to another...11-05-2020, 04:12 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: October 28, 2020 | site |
(October 28, 2020) - - Today, October 28, 2020, the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- Today, the FDA updated an immediately in effect guidance, Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. This update expands the scope of the guidance to include an additional device type: Gaseous-Phase Carbon-Dioxide Gas Analyzer (product code CCK), which includes capnographs and devices with a capnography feature.
- Yesterday, the FDA approved two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical
10-31-2020, 12:14 AM -
U.S. Department of Agriculture says More than $7 Billion Paid in Second Round of USDA Coronavirus Food Assistance Program | site |
(October 26, 2020) - - Today, October 26, 2020, the U.S. Department of Agriculture (USDA) published the following information: (Washington, D.C., Oct. 26, 2020) – U.S. Secretary of Agriculture Sonny Perdue today announced that in the first month of the application period, the USDA Farm Service Agency (FSA) approved more than $7 billion in payments to producers in the second round of the Coronavirus Food Assistance Program. CFAP 2 provides agricultural producers with financial assistance to help absorb some of the increased marketing costs associated with the COVID-19 pandemic. “America’s agriculture communities are resilient, but still face many challenges due to the COVID-19 pandemic. These payments directed by President Trump will continue to help this critical industry recoup some of their losses from ongoing market disrupti...10-27-2020, 02:37 PM -
U.S. Department of Agriculture Announces Fourth Round of the Farmers to Families Food Box Program | site |
(October 23, 2020) - - Today, October 23, 2020, the U.S. Department of Agriculture published the following information:
(Washington, D.C., Oct. 23, 2020) – The U.S. Department of Agriculture (USDA) today announced it has authorized $500 million for a fourth round of purchases for the USDA Farmers to Families Food Box Program. USDA is issuing solicitations for the fourth round to existing Basic Ordering Agreement (BOA) holders and expects to award contracts by Oct. 30 for deliveries of food boxes from Nov. 1 through Dec. 31, 2020. In the fourth round, as in the third round, states have been allocated boxes based on the internal need of the state. The program will continue the purchase of combination boxes to include fresh produce, dairy products, fluid milk and meat products. The program also will continue to require that proposals illustrate ...10-24-2020, 10:19 PM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: Daily Roundup October 23, 2020
| site |
(October 23, 2020) - - Today, October 23, 2020, the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- On Thursday, the FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19, for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. The FDA revised the Emergency Use Authorization (EUA) for Veklury to remove those uses that are now approved under Gilead’s New Drug Application (NDA). The EUA for Veklury continues
10-23-2020, 07:19 PM -
U.S. Food and Drug Administration Approves First Treatment for COVID-19 | site |
(October 22, 2020) - - Today, October 22, 2020, the U.S. Food and Drug Administration (FDA) published the following information:
Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered und...10-23-2020, 05:22 AM -
U.S. Food and Drug Administration Coronavirus (COVID-19) Update: Daily Roundup October 20, 2020 | site |
(October 20, 2020) - - Today, October 20, 2020, the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
The FDA posted a new “FDA Insight” podcast featuring Deputy Commissioner Anand Shah, M.D., and Dr. Peter Marks, the Director of FDA's Center for Biologics Evaluation and Research, discussing the upcoming Vaccines and Related Biological Products Advisory Committee meeting on October 22, 2020.- In a new “FDA Voices”, entitled the FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines, Peter Marks, M.D., Ph.D., highlights the value of transparency. Dr. Marks states that facilitating the development
10-21-2020, 09:03 PM -
Trump Administration Welcomes Amazon to the U.S. Food Loss and Waste 2030 Champions | site |
(October 16, 2020) - - Today, October 16, 2020, the U.S. Department of Agriculture published the following information:
WASHINGTON (Oct. 16, 2020) — Today, on World Food Day, U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler and U.S. Department of Agriculture (USDA) Secretary Sonny Perdue welcomed Amazon as a new member of the U.S. Food Loss and Waste 2030 Champions. Champions are U.S. businesses and organizations that pledge to reduce food loss and waste in their own operations by 50 percent by the year 2030. The commitment and action of these businesses will help the U.S. move closer to the national goal, protect and save valuable resources, and improve food system efficiencies while reducing waste.
“The Trump Administration is leading the way in combating food waste, and the addition of Amazon to our Food Loss...10-20-2020, 12:57 AM -
U.S. Food and Drug Administration Approves First Treatment for Ebola Virus | site |
(October 14, 2020) - - The U.S. Food and Drug Administration (FDA) published today, October 14, 2020, the following information:
Today, the U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.
“Today’s action demonstrates the FDA’s ongoing commitment to responding to public health threats—both domestically and abroad—on the basis of science and data,” said FDA Commissioner Stephen M. Hahn, M.D. “This approval was made possible because of our steadfast dedication to facilitate the development of safe and effective treatments for infectious diseases as part of our vital public health mission.”
Zaire ebolavirus, commonly known as Ebola virus, is one...10-15-2020, 01:13 AM -
U.S. Food and Drug Administration Coronavirus - - - COVID-19 - - - Update: Daily Roundup October 13, 2020 | site |
(October 13, 2020) - - Today, October 13, 2020, the U.S. Food and Drug Administration published the following information:
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:- Today, the FDA issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Many molecular influenza (flu) viruses and respiratory syncytial viruses (RSV) tests require the same critical components as many SARS-CoV-2 molecular assays. The policy outlined in this guidance aims to help expand access to certain FDA-cleared molecular tests intended for detection and identification of flu viruses, including molecular influenza tests that also detect and identify
10-14-2020, 11:27 PM -
U.S. Department of Agriculture Announces Contracts for Round 3 of the Farmers to Families Food Box Program | site |
(September 17, 2020) - - Today, September 17, 2020, the U.S. Department of Agriculture published the following information:
(Washington, D.C., September 17, 2020) – Following President Donald Trump’s approval to include up to an additional $1 billion in the Farmers to Families Food Box Program, U.S. Secretary of Agriculture Sonny Perdue announced the U.S. Department of Agriculture (USDA) has approved up to $1 billion in contracts to support American producers and communities in need through the USDA Farmers to Families Food Box Program. Earlier this week, USDA reached a milestone of having distributed more than 90 million food boxes in support of American farmers and families affected by the COVID-19 pandemic. “These contract awards will go to vendors who submitted the strongest proposals in support of American agriculture and the Ame...09-21-2020, 09:21 AM -
Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020| site |
(May 28, 2020) - - Today (May 28, 2020), the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:- The FDA issued an Emergency Use Authorization for the Stryker Sustainability Solutions (SSS) VHP N95 Respirator Decontamination System (RDS). This product uses vapor hydrogen peroxide (VHP) to decontaminate compatible N95 respirators that are, or potentially are, contaminated with SARS-CoV-2 or other pathogenic microorganisms for multiple-user reuse by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. N95 respirators containing cellulose-based materials
05-29-2020, 02:26 AM -
U.S. Food and Drug Administration Provides Promised Transparency for Coronavirus COVID-19 Antibody Tests| site |
(May 21, 2020) - - The U.S. Food and Drug Administration (FDA) published today (May 21, 2020) the following information:
Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA. FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on...05-26-2020, 12:09 AM -
U.S. Food and Drug Administration Expedites Review of Diagnostic Tests to Combat COVID-19 | site |
(March 30, 2020) - - Today (March 30, 2020), the U.S. Food and Drug Administration (FDA) published the following information:
March 30, 2020
Statement From:
Commissioner of Food and Drugs - Food and Drug Administration
Stephen M. Hahn M.D.
The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed. Moreover, as in previous...03-31-2020, 09:20 PM -
U.S. Food and Drug Administration Approves First Treatment for Group of Progressive Interstitial Lung Diseases| site |
(March 9, 2020) - - Today, the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time.
“The FDA continues to encourage the development of therapies for patients with limited or no treatment options,” said Banu Karimi-Shah, M.D., acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases...03-10-2020, 12:19 AM -
U.S. Agriculture Secretary Perdue Announces New Food Safety and Inspection Service Leadership| site |
(February 25, 2020) - - Today, the U.S. Department of Agriculture published the following information: (Washington, D.C, February 25, 2020) – U.S. Secretary of Agriculture Sonny Perdue today announced the appointment of Paul Kiecker to serve as Administrator of the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS). Mr. Kiecker will be assuming the role following the departure of Administrator Carmen Rottenberg, who is departing federal service after a career spanning two decades. “Ensuring the safety of America’s food supply is USDA’s most important responsibility, and one that Carmen carried out with dedication and vision. I know she will continue her passion for food safety in the private sector,” said Secretary Perdue. “Carmen is a true public servant and ushered in an era of modernization at the Food Safety and ...02-27-2020, 08:40 PM -
Coronavirus Update: U.S. Food and Drug Administration Steps to Ensure Quality of Foreign Products| site |
(February 24, 2020) - - Today (February 24, 2020), the U.S. Food and Drug Administration (FDA) published the following information:
Coronavirus Update: FDA steps to ensure quality of foreign products
February 24, 2020
Statement From:
Commissioner of Food and Drugs - Food and Drug Administration
Stephen M. Hahn M.D.
Associate Commissioner for Regulatory Affairs - Office of Regulatory Affairs
Judith A. McMeekin Pharm.D.
Recently, we provided an update on FDA-wide activities we are engaged in related to the novel coronavirus outbreak: COVID-19. We continue to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply...02-26-2020, 04:42 AM -
U.S. Food and Drug Administration takes Action with Indian Government to Protect Consumers From Illicit Medical Products | site |
First Bilateral Enforcement Operation with India Stopped Approximately 500 Shipments Through International Mail
(February 18, 2020) - - Today, the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers over the course of an operation that took place in January.
“With standards and regulations varying in each country, U.S. consumers face hazards when they order drugs and other FDA-regulated products from unauthorized foreign sources and receive them through the international...02-18-2020, 10:10 PM -
Food Safety Alert - - - CDC Investigating Outbreak of Listeria Infections Linked to Hard-Boiled EggsCenters for Disease Control and Prevention Food Safety Alert - - - CDC Investigating Outbreak of Listeria Infections Linked to Hard-Boiled Eggs | site |
(December 19, 2019) - - Today, the Centers for Disease Control and Prevention (CDC) published the following information:
A CDC food safety alert regarding a multistate outbreak of Listeria infections linked to hard-boiled eggs has been posted: https://www.cdc.gov/listeria/outbrea...-19/index.html
Key points:- CDC, the U.S. Food and Drug Administration (FDA), and state public health officials are investigating an outbreak of Listeria monocytogenes infections that has sickened seven people in five states (Florida, Maine, Pennsylvania, South Carolina, and Texas).
- Four people have been hospitalized. One death has been reported from Texas. One illness was reported in a newborn who was infected with Listeria while the mother was pregnant; the newborn survived.
- Interviews with ill
12-19-2019, 08:01 PM -
U.S. Food and Drug Administration says California-based Food Manufacturer Agrees to Stop Production after Repeated Food Safety Violations | site |
(November 26, 2019) - - Today, the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration announced that recently Golden Gate Soy Products, a California-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements. This action follows several inspections conducted by the FDA, which found Listeria monocytogenes (L. mono) in the company’s food preparation area and that the company was holding food for distribution in insanitary conditions. U.S. Magistrate Judge Jacqueline Scott Corley for the Northern District of California entered a consent decree of permanent injunction on Nov. 22, 2019, between the U.S. and Golden Gate Soy Products Inc., and the company...12-02-2019, 02:05 AM -
U.S. Food and Drug Administration issues Warning Letter to Dollar Tree Stores for Receiving Potentially Unsafe Drugs | site |
(November 14, 2019) - - Today (November 14, 2019), the U.S. Food and Drug Administration (FDA) published the following information:
The U.S. Food and Drug Administration has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law. The warning letter outlines multiple violations of current good manufacturing practices at contract manufacturers used to produce Dollar Tree’s Assured Brand OTC drugs as well as other drug products sold at Dollar Tree and Family Dollar stores. “Protecting patient health and safety is our highest priority, and the FDA continues to investigate and take action against companies that place U.S. patients at risk. Americans expect and deserve...11-25-2019, 04:00 AM -
U.S. Food and Drug Administration Approves First Targeted Therapy to Treat Patients with Painful Complication of Sickle Cell Disease | site |
(November 15, 2019) - - The U.S. Food and Drug Administration (FDA) published (today) the following information: Today, the U.S. Food and Drug Administration approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older. “Hope has never been higher for people living with sickle cell disease and their families and supporters, with a pipeline of new treatments on the horizon, like the one being approved today, and several initiatives underway to better utilize current tools in the battle against the painful and deadly blood disorder,” said Acting FDA Commissioner Adm. Brett P. Giroir, M.D. “The opportunity...11-21-2019, 03:53 PM -
U.S. Agriculture Secretary Perdue Statement on Newly Appointed Food, Nutrition, and Consumer Services Leadership | site |
(August 19, 2019) - - Today, the U.S. Department of Agriculture published the following information: (Washington, D.C., August 19, 2019) – U.S. Secretary of Agriculture Sonny Perdue has sworn in Brandon Lipps as Deputy Under Secretary of the Food, Nutrition, and Consumer Services (FNCS) and Pam Miller as the Administrator of the Food and Nutrition Service (FNS) at the U.S. Department of Agriculture (USDA). Secretary Perdue issued the following statement: “I am excited to welcome Brandon Lipps and Pam Miller to these new roles within the Department and thank them for their hard work up to this point. Both Brandon and Pam have extensive experience in nutrition policy and have already been serving in FNCS leadership positions. I am confident they will hit the ground running and continue the great work the Food, Nutrition, and Consumer Services d...08-22-2019, 07:20 PM -
Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the Regulation of Cell-cultured Food Products from Cell Lines of Livestock and Poultry
(November 16, 2018) - - Today, the U.S. Food and Drug Administration (FDA) published the following "Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry": Last month, the U.S. Department of Agriculture and the U.S. Food and Drug Administration held a public meeting to discuss the use of livestock and poultry cell lines to develop cell-cultured food products. At this meeting, stakeholders shared valuable perspectives on the regulation needed to both foster these innovative food products and maintain the highest standards of public health. The public comment period will be extended and will remain open through December 26, 2018. Afte...11-16-2018, 08:15 PM -
Statement from U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D., on new Steps to Strengthen and Modernize Agency’s Oversight and Reporting of Inspections for Sterile Injectable Drugs
(November 9, 2018) - - Today, the U.S. Food and Drug Administration (FDA) issued the following statement: Manufacturing inspections are one of the FDA’s most important tools for ensuring the quality of pharmaceutical products used by American patients. Inspections help us to identify manufacturing issues that could pose potential risks to patients, or problems that could contribute to drug shortages, enabling us to engage manufacturers to address and resolve issues. Because of the importance of the data that we gather from these inspections, there’s increasing need to more efficiently collect and analyze the information we gather during inspections to give us even better and timelier in...11-12-2018, 09:03 PM -
U.S. Food and Drug Administration Authorizes Emergency Use of First Ebola Fingerstick Test with Portable Reader
(November 9, 2018) - - The U.S. Food and Drug Administration published (today) the following information:
Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated. The test, called the DPP Ebola Antigen System, is used with blood specimens, including capillary “fingerstick” whole blood, from individuals with signs and symptoms of Ebola virus disease (EVD) in addition to...11-10-2018, 03:50 AM -
Statement from U.S. Food and Drug Administration Commissioner Scott Gottlieb on the FDA’s new Consideration of Labeling for Sesame Allergies
(October 29, 2018) - - Today, the U.S. Food and Drug Administration (FDA) published the following statement from FDA Commissioner Scott Gottlieb, M.D.: Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods. In particular, the undeclared presence of allergens in foods – the leading reason for food recalls – continues t...10-30-2018, 12:30 AM -
U.S. Food and Drug Administration Launches Global Operation to Crack Down on Websites Selling Illegal, Potentially Dangerous Drugs; including Opioids
Illegally marketed opioids and drugs claiming to treat cancer and HIV are among the products targeted, along with the websites that sell them
(October 23, 2018) - - The U.S. Food and Drug Administration (FDA), in partnership with international regulatory and law enforcement agencies, acted this week to target 465 websites that illegally sell potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers.
This effort was part of Operation Pangea XI, the eleventh annual International Internet Week of Action (IIWA). This is a global cooperative effort, led by Interpol, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products...10-27-2018, 03:51 AM -
U. S. Department of Agriculture Announces Receipt of 136 Expressions of Interest in Hosting Economic Research Service and the National Institute of Food and Agriculture
(Washington, D.C. - - (October 22, 2018) – U.S. Secretary of Agriculture Sonny Perdue today announced that the U.S. Department of Agriculture (USDA) has received 136 expressions of interest from parties in 35 states interested in becoming the new homes of the Economic Research Service (ERS) and the National Institute of Food and Agriculture (NIFA). In August, Perdue announced that most ERS and NIFA personnel would be moving to outside the National Capital Region by the end of 2019 and invited interested parties to submit proposals, with a deadline which had been extended to October 15, 2018. USDA intends to select the new location or locations by January 2019 and will retain a consultant with expertise in relocations. ...10-23-2018, 05:52 AM -
U.S. Food and Drug Administration Approves New DNA-based Test to Determine Blood Compatibility
Test is first approved to report genotypes as final results
(October 11, 2018) - - The U.S. Food and Drug Administration today approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC) types. ID CORE XT is the second molecular assay approved for use in transfusion medicine, and the first to report genotypes as final results. “The approval of the ID CORE XT Test can streamline blood compatibility testing and provides an additional alternative to testing blood with antisera,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We know that DNA testing holds great promise – to prov...10-12-2018, 03:54 AM -
U.S. Food and Drug Administration Allows Marketing of First Self-fitting Hearing Aid Controlled by the User
(October 5, 2018) - - The U.S. Food and Drug Administration (FDA) today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider. “Hearing loss is a significant public health issue, especially as individuals age,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. “Today’s marketing authorization provides certain patients with access to a new hearing...10-06-2018, 05:49 PM -
Remarks from U.S. Food and Drug Administration Deputy Commissioner Anna Abram as Prepared for Delivery to the 2018 Intergovermental Meeting on Drug Compounding
(September 25, 2018) Good morning and welcome. I am Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis here at the Food and Drug Administration. I would like to thank you all for traveling from near and far to be with us today to participate in our seventh intergovernmental meeting on drug compounding. Wherever you hail from, and whether this is your first or seventh meeting, we’re glad to have you join us to continue our ongoing dialogue about ways to reduce the risks associated with compounded drug products and improve collaboration between FDA and the states. We greatly value our work with you, and we feel strongly that our partnerships with you are critical to maintaining robust oversight of compounder...09-26-2018, 02:12 AM -
U.S. Department of Agriculture Provides Additional Food Options to SNAP Participants Impacted by Hurricane Florence
SNAP participants may use benefits to purchase hot and prepared foods and receive additional time to report food losses
Washington, DC - - (September 17, 2018) - - The U.S. Department of Agriculture (USDA) yesterday approved a waiver that will allow participants in the USDA’s Supplemental Nutrition Assistance Program (SNAP) in North Carolina to buy hot foods with their benefits through October 31, 2018. USDA Secretary Sonny Perdue emphasized the importance of the waiver, noting that many North Carolina residents evacuated to shelters cannot store food and are lacking access to cooking facilities as a result. “As the state of North Carolina works to recover from this storm, USDA stands ready to provide common-sense flexibilities to help them meet t...09-17-2018, 10:58 PM -
Statement from Binita Ashar, M.D., of the U.S. Food and Drug Administration’s Center for Devices and Radiological Health on Agency’s Commitment to Studying Breast Implant Safety
(September 14, 2018) - - Today, the U.S. Food and Drug Administration published the following information: Choosing to obtain a breast implant, whether for augmentation or reconstruction, is a deeply personal choice, from the initial decision to undergo breast implant surgery to the size, material and surface texture. These types of decisions should be discussed between a patient and their provider in a transparent and balanced way with clear information about the benefits and risks of the breast implants and the procedure. As a public health agency, we play an important role in ensuring that patients seeking breast augmentation and breast reconstruction have accurate information regarding the benefits ...09-14-2018, 08:22 PM -
U. S. Food and Drug Administration Takes New Steps to Address Epidemic of Youth e-cigarette Use, including a Historic Action Against more than 1,300 Retailers and 5 Major Manufacturers for their Roles Perpetuating Youth Access
Warning letters and civil money penalty complaints to retailers are largest coordinated enforcement effort in agency history; FDA requests manufacturers provide plan for mitigating youth sales within 60 days; warns it may restrict flavored e-cigarettes to address youth epidemic
The U.S. Food and Drug Administration (FDA) published the following information:
(September 12, 2018) - - The U.S. Food and Drug Administration today announced a series of critical and historic enforcement actions related to the sale and marketing of e-cigarettes to kids. In the largest coordinated enforcement effort in the FDA’s history, the agency...09-13-2018, 11:38 PM -
Statement from FDA Commissioner Scott Gottlieb, M.D., on New Guidance to Help Manufacturers Implement Protections Against Potential Attacks on the U.S. Food Supply
(June 19, 2018) - - Today, U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D., issued the following Statement: In the U.S., we enjoy one of the safest food supplies in the world. The FDA takes its responsibility to protect the U.S. food supply very seriously. And while we work diligently to prevent accidental contaminations, it’s also our duty to take measures to protect our food from those who seek to deliberately do us harm. The likelihood of an incident at a particular facility is low, but the intentional adulteration of the U.S. food supply represents a very serious threat – one that could have devastating public health consequences. That’s why the FDA is taking important steps toward preventing...06-20-2018, 11:44 PM -
U.S. Food and Drug Administration Approves First Generic Versions of Suboxone Sublingual Film, which may Increase Access to Treatment for Opioid Dependence
Agency is taking additional steps to advance the development of new FDA-approved treatments for opioid dependence and encourage their more widespread use
(June 14, 2018) - - The U.S. Food and Drug Administration today approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. “The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broa...06-18-2018, 06:35 AM -
U.S. Food and Drug Administration Approves First Artificial Iris
(May 30, 2018) - - The U.S. Food and Drug Administration today approved the first stand-alone prosthetic iris in the United States, a surgically implanted device to treat adults and children whose iris (the colored part of the eye around the pupil) is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye. “Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. “Today’s approval of the first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmeti...06-02-2018, 01:51 PM -
As Part of Efforts to Combat Opioid Crisis, FDA Launches Innovation Challenge to Spur Development of Medical Devices ‒ including Digital Health and Diagnostics ‒ that Target Pain, Addiction and Diversion
Agency will work closely with selected applicants to accelerate product development
(May 30, 2018) - - Today, the U.S. Food and Drug Administration (FDA) published the following information: As part of the agency’s ongoing commitment to address the epidemic of opioid misuse and abuse, the U.S. Food and Drug Administration today launched an innovation challenge to spur the development of medical devices, including digital health technologies and diagnostic tests that could provide novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain. Despite recent advances in some of these areas, there are still many opportunities to a...05-30-2018, 12:46 PM -
U.S. Food and Drug Administration Permits Marketing of Artificial Intelligence Algorithm for Aiding Providers in Detecting Wrist Fractures
(May 24, 2018) - - Today, the U.S. Food and Drug Administration permitted marketing of Imagen OsteoDetect, a type of computer-aided detection and diagnosis software designed to detect wrist fractures in adult patients. “Artificial intelligence algorithms have tremendous potential to help health care providers diagnose and treat medical conditions,” said Robert Ochs, Ph.D., acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This software can help providers detect wrist fractures more quickly and aid in the diagnosis of fractures.” The OsteoDetect software is a computer-aided detection and diagnostic software that uses an artificial...05-24-2018, 09:44 PM -
U.S. Food and Drug Administration Warns Companies Selling Illegal, Unapproved Kratom Products Marketed for Opioid Cessation, Pain Treatment and Other Medical Uses
(May 22, 2018) - - Today, the U.S. Food and Drug Administration published the following information:
The U.S. Food and Drug Administration has issued warning letters to three marketers and distributors of kratom products – Front Range Kratom of Aurora, Colorado; Kratom Spot of Irvine, California and Revibe, Inc., of Kansas City, Missouri – for illegally selling unapproved kratom-containing drug products with unproven claims about their ability to help in the treatment of opioid addiction and withdrawal. The companies also make claims about treating pain, as well as other medical conditions like lowering blood pressure, treating cancer and reducing neuron damage caused by strokes. “Despite our warnings th...05-23-2018, 11:53 AM -
U.S. Food and Drug Administration Approves Novel Preventive Treatment for Migraine
(May 17, 2018) - - Today, the U.S. Food and Drug Administration published the following information: The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks. “Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We need new treatments for this painful and often debilitating condition.” Patients...05-22-2018, 10:00 PM -
U.S. Food and Drug Administration Approves the First Non-opioid Treatment for Management of Opioid withdrawal Symptoms in Adults
Encouraging more widespread innovation and development of safe and effective treatments for opioid use disorder remains top agency priority
(May 16, 2018) - - The U.S. Food and Drug Administration today approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD. “As part of our commitment to support patients struggling with addiction, we’re dedicated to encourag...05-17-2018, 11:55 AM -
U.S. Agriculture Secretary Perdue Applauds President Trump’s Selection for USDA’s Under Secretary for Food Safety
Washington, DC - - (May 4, 2018) - - U.S. Secretary of Agriculture Sonny Perdue today applauded President Donald J. Trump’s selection of Dr. Mindy Brashears to be the U.S. Department of Agriculture’s (USDA) Under Secretary for Food Safety. After the announcement, Secretary Perdue issued the following statement: “Food safety is at the core of USDA’s mission, because it directly affects the health and well-being of millions of Americans every day. President Trump has made an excellent choice in Dr. Mindy Brashears, and I am excited to have her join the team. Dr. Brashears has spent decades finding ways to improve food safety standards through innovation, invention, and leadership on research missions across the globe. I look forward to her bringing that wealth of expertis...05-05-2018, 10:07 PM -
U.S. Department of Agriculture Seeks Comments on Proposed Rule for National Bioengineered Food Disclosure Standard
Washington, DC - - (May 3, 2018) - - The U.S. Department of Agriculture today invited public comment on the proposed rule to establish the National Bioengineered Food Disclosure Standard mandated by Congress in 2016. The standard will provide a uniform way to offer meaningful disclosure for consumers who want more information about their food and avoid a patchwork system of state or private labels that could be confusing for consumers and would likely drive up food costs. “This rulemaking presents several possible ways to determine what foods will be covered by the final rule and what the disclosure will include and look like,” said Agriculture Secretary Sonny Perdue. “We are looking for public input on a number of these key decisions before a final rul...05-03-2018, 05:12 PM