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 | site |




Information contained in U.S. Food and Drug Administration (FDA) press release dated: May 17, 2022

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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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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. ...

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...

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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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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U.S. Food and Drug Administration Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy | site |



Drug Is Given Before Chemotherapy to Protect Bone Marrow Function


(Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 12, 2021) Today, the U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage (when the cancer has spread beyond the lungs) small cell lung cancer. Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin- dependent kinase 4/6, a type of enzyme. “For patients with extensive-stage small cell lung cancer, protecting bone marrow function may help make their chemotherapy safer and allow them to complete their course of treatment on time an...

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

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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

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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

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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...

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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FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 4, 2021)

January 04, 2021
Statement From:
Acting Director - Center for Drug Evaluation and Research
Deputy Center Director for Operations - Center for Drug Evaluation and Research | CDER
Patrizia Cavazzoni M.D. Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. These advances have contributed to an increase in development and approval of drugs for the treatment of rare diseases in recent years. In fact, in the past eight years, the U.S. Food and Drug Administration has approved more than twice as many drugs for rare diseases, often referred to as orphan drug...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 30, 2020 | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release: December 30, 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 published a new toolkit to help stakeholders communicate in English and Spanish about hand sanitizer safety and use during the COVID-19 pandemic. New materials include social media messages and graphics, consumer information, and health professional messaging. Furthermore, a new COVID-19 Communication Toolkits webpage provides links to all FDA toolkits on COVID-19 topics to help everyone communicate accurate and timely information to patients, the public, and health care professionals.

• In a new FDA Voices entitled, 2020 at FDA: A Year of Unparalleled Contributions to Public Health, FDA Commissioner

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U.S. Food and Drug Administration Approves First Generic of Drug Used to Treat Severe Hypoglycemia | site |


Agency Supports Development of Complex Generic Drugs to Improve Competition and Access to More Affordable Medicines


(Information contained in U.S. Food and Drug Administration [FDA] press release: December 28, 2020) Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus. The drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum (the first part of the small intestine beyond the stomach), small bowel and colon when diminished intestinal motility (reduced ability to move) would be advantageous. “Glucagon for injection has been approved for use in the U.S. for more than 20 years, but unti...