The latest from FDA

Apr 4, 2024

Public health emergency response and other updates from FDA since our last MCMi e-mail include:

March 29, 2024: Questions and Answers Regarding Milk Safety During Highly Pathogenic Avian Influenza (HPAI) Outbreaks
March 28, 2024: FDA Principal Deputy Commissioner Dr. Namandjé N. Bumpus has launched a new video series, FDA In Your Day. The first video covers measles vaccines, drug shortages, AI, and FDA-approved products for two rare diseases.
March 26, 2024: FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects
March 22, 2024: FDA's Center for Drug Evaluation and Research (CDER) established a new Quantitative Medicine Center of Excellence.
March 11, 2024: FDA Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical Product Safety, and Strengthen Public Health
March 5, 2024: FDA is accepting proposals for FY 2024-2025 funding opportunities to collect data on antimicrobial use in animals.
March 5, 2024: Use of Trivalent Influenza Vaccines for the 2024-2025 U.S. Influenza Season
March 1, 2024: Consumer Update: Vaccination Is the Best Protection Against Measles
March 2024: The HHS Office of Long COVID Research and Practice published an update: Implementation of the Government-wide Response to Long COVID (PDF)

Artificial intelligence update

FDA publishes AI paper

FDA published a new paper, Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together (PDF), which outlines specific focus areas regarding the development and use of AI across the medical product lifecycle.
The multi-center effort from FDA’s CDER, Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluation and Research (CBER), and the Office of Combination Products (OCP) supports approaches to the safe, secure, ethical, and trustworthy development and use of AI. (March 15, 2024)

Graphic representing artificial intelligence (AI) and SARS-CoV-2, the virus that causes COVID-19

Related links

Harnessing the Potential of Artificial Intelligence by FDA Commissioner Dr. Robert M. Califf
Artificial Intelligence and Medical Products - new FDA webpage

COVID-19 update

FDA authorizes new long-acting monoclonal antibody for pre-exposure prevention of COVID-19 in certain immunocompromised individuals

FDA issued an Emergency Use Authorization (PDF) for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).
Pemgarda is authorized for individuals:

who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2;
and who have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

More information:

Drug shortage updates

New public portal

FDA launched a new portal for patients, consumers, and health care professionals to report potential drug shortage issues directly into CDER’s NextGen system without creating a NextGen account. (March 18, 2024)

HHS releases white paper focused on preventing drug shortages

The U.S. Department of Health and Human Services (HHS) released a white paper, Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States, highlighting steps HHS has taken to prevent and mitigate drug shortages and proposing additional solutions for policymakers to consider.
FDA recognizes that a robust, resilient and safe drug supply chain is essential for public health and national security. We remain committed to partnering across government, academia, and industry to strengthen and diversify the supply chain, further address drug shortages and ensure Americans continue to have access to drugs that are of high quality, safe and effective. (April 2, 2024)

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