CDC Interim Guidance for Employers to Reduce Exposure to Novel Influenza A (Such as H5N1 Bird Flu) for People Working with or Exposed to Animals
November 12, 2024
This updated interim guidance identifies work tasks that may pose an increased risk of worker exposure to novel influenza A viruses associated with disease in humans and provides recommended controls for each level. Specific recommendations for these work tasks may be updated as CDC learns more during this evolving situation.
CDC Expands Guidance to Better Protect Farm Workers and Livestock Owners to Lower the Risk of Becoming Infected with Bird Flu
November 8, 2024
This report highlights the need to offer testing and treatment to workers with exposure to sick animals, describes the need to improve and clarify guidance to farm workers and their employers about what personal protective equipment (PPE) to use, and how best to use it to protect themselves and prevent the spread of the virus.
Status of the Milk Supply
Last updated November 8, 2024
The process of pasteurization has helped ensure the health of the American public for more than 100 years. Pasteurization kills harmful bacteria and viruses by heating milk to a specific temperature over time. Even if HPAI virus is detected in raw milk, the current pasteurization process (HTST – High temperature, short time) will inactivate HPAI virus.
FDA Issues Final Guidance on 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
November 20, 2024
Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review. This guidance supersedes the previous "510(k) Third Party Review Program" guidance, clarifying how the FDA will use third party review organizations to review 510(k) submissions and may use them to review EUA requests during a future public health emergency.
Cue COVID-19 Test and Cue COVID-19 Test for Home and Over The Counter (OTC) Use
October 9, 2024
Cue Health Inc. indicated that they have ceased manufacture, shipping and distribution of the authorized product and requested that the EUA be revoked. FDA understands that as of the date of this letter any remaining viable Cue COVID-19 Test cartridges and Cue COVID-19 Test for Home and Over The Counter (OTC) Use cartridges in distribution in the United States cannot be used due to the disabling of the Cue Health Mobile Application (Cue Health App) required to run the test.
Ever hear about a food or drug being recalled and wonder “Where can I get more information ?” Check out this episode of FDA In Your Day to learn how you can find more information on recalls.
Understanding Drug Recalls | Q&A with FDA Podcast
Understand drug recalls better with Dr. Ileana Elder in the latest Q&A with FDA Podcast.
Know When and How to Use Antibiotics, and When to Skip Them
Antibiotics can be like little superheroes … but: they don’t treat everything! Antibiotics treat a number of different infections caused by bacteria. But they do NOT work on illnesses caused by viruses like the common cold. Get 5 tips about taking the antibiotics you are prescribed and learn why it is important not to misuse or overuse antibiotics.
A free public workshop to discuss potential next steps to promote the continued evolution and consistent application of real-world data in drug development.
A virtual public workshop to discuss methodological challenges related to patient experience data, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling
Thanks for reading. This newsletter is produced by the FDA Office of Public Health Preparedness and Response, in the Office of the Chief Medical Officer (OCMO).
