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  • FDA Coronavirus COVID-19 Update - - - January 19, 2021

    FDA Coronavirus COVID-19 Update - - - January 19, 2021

    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:...
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  • USDA Offers Additional Assistance for Certain Producers Through Coronavirus Food Assistance Program

    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...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - January 15, 2021

    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:
    ...
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  • U.S. Food and Drug Administration Releases Artificial Intelligence/Machine Learning Action Plan

    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...
    See more | Go to post

  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - January 5, 2021

    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
    ...
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  • USDA Announces Continuation of the Farmers to Families Food Box Program, Fifth Round of Food Purchases

    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...
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  • FEMA Reimburses nearly 7 Million Dollars to Massachusetts for COVID-19 Food Security Response

    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...
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  • FDA Coronavirus COVID-19 Update - - - December 28, 2020

    FDA Coronavirus COVID-19 Update - - - December 28, 2020

    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
    ...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - December 22, 2020

    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
    ...
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  • FDA Coronavirus (COVID-19) Update - - - December 21, 2020

    FDA Coronavirus (COVID-19) Update - - - December 21, 2020

    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
    ...
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  • FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

    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...
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  • U.S. Food and Drug Administration Statement on Vaccines and Related Biological Products Advisory Committee Meeting

    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
    ...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - December 17, 2020

    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
    ...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - December 16, 2020

    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
    ...
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  • FDA Authorizes Marketing of New Implant to Repair a Torn ACL

    FDA Authorizes Marketing of New Implant to Repair a Torn ACL

    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...
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  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - January 19, 2021
    by Staff Reporter 1
    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:...
    01-20-2021, 12:14 AM
  • Staff Reporter 1
    USDA Offers Additional Assistance for Certain Producers Through Coronavirus Food Assistance Program
    by Staff Reporter 1
    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, 12:27 PM
  • Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - January 15, 2021
    by Staff Reporter 1
    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:
    ...
    01-17-2021, 05:15 AM
  • Staff Reporter 1
    U.S. Food and Drug Administration Releases Artificial Intelligence/Machine Learning Action Plan
    by Staff Reporter 1
    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, 07:54 PM
  • Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus COVID-19 Update - - January 5, 2021
    by Staff Reporter 1
    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
    ...
    01-06-2021, 02:05 AM

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