The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders. You can read the FDA regulatory update for stakeholders below.
November 12, 2024
Dear Colleague,
The FDA works to safeguard the public against potential health risks, ensures the safety and efficacy of medical products, and the safety of our nation’s food supply and cosmetics. The Public Engagement Staff is responsible for engaging, educating and communicating with external partners including patients, caregivers, health care providers, consumers, academia and trade associations on the agency’s policy priorities. We also recognize the invaluable work of our external partners in achieving these goals. Your partnership, knowledge and engagement in the public health space are appreciated.
You may not realize it, but most flour is a raw food. It's considered raw because it hasn't been treated to kill germs. Cooking or baking is what kills those germs in flour.
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FDA Voices
One Health - Optimal Public Health Outcomes for Humans and Animals in Our Shared Environment
By: Robert M. Califf, MD, Commissioner of Food and Drugs
November 3, 2024, was One Health Day, bringing attention to the pressing need for collaborative solutions for interdependent human, animal, and environmental health concerns. I’d like to catch up with you today about a component of the FDA’s mission to collaborate across disciplines and sectors to promote the health of humans and animals; and taking into account agricultural and environmental issues, using science, technology, and innovation to better understand and define policies that involve these intersections.
The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on adulteration associated with decomposition and/or histamine identified during surveillance sampling and testing of fish and fishery products susceptible to histamine formation.
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.
ICYMI!
Should You Give Kids Medicine for Coughs and Colds?
Although most colds in children don’t cause serious complications, they can cause stress and worry in parents and caregivers. It’s understandable that you might want to give your child medicine to treat a cold. But most children will get better on their own, and cough or cold medicine will not change the natural course of a cold or make it go away faster.
Workshop Location FDA White Oak Campus Building 31, Conference Center, The Great Room 10903 New Hampshire Ave. Silver Spring, MD 20993
The goal of the workshop is to discuss the current nonprescription analgesic/antipyretic treatment options available for children 2 to less than 12 years of age and the development needs for additional oral nonprescription treatment options containing acetaminophen and/or NSAIDs for pain, fever, or both for the same pediatric population.
In conjunction with the European Medicines Agency (EMA), the FDA Oncology Center of Excellence (OCE) will hold a one-hour Conversations on Cancer public panel discussion on November 19, 2024, to examine an array of challenging decisions faced by members of the pediatric oncology community.
The FDA or Agency is announcing a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Over-the-Counter Monograph Drug User Fee program (OMUFA) for fiscal years (FYs) 2026 through 2030. The meeting agenda, public docket information, additional materials, and any other updates will also be posted to this website as they become available.
This webinar will provide an update and overview on the final M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms guideline including major changes from the draft guideline and FDA’s current bioequivalence (BE) guidance, delineate FDA’s planning on the implementation of M13A, and address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline.
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts
About Us
The Public Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations. For more information, please contact us at: PublicEngagement@fda.hhs.gov. For patient specific inquiries, please contact us at: Patients Ask FDA.
November 12, 2024
