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. 

Sincerely,

The Public Engagement Staff
Public Engagement Staff | FDA

Updates

• November 8, 2024 - Hurricane Helene: Baxter's manufacturing recovery in North Carolina
• November 8, 2024 - FDA Roundup
• November 7, 2024 - FDA Seeks Public Input on Experiences with Export Certification in the Form of Lists (Export Lists) for Human Food Products
• November 7, 2024 - FDA Updates Breakthrough Devices Program Metrics and Marketing Authorizations List
• November 7, 2024 - FDA Renews Authorization for 8 General Snus Products to be Marketed with Reduces Risk Claim
• November 7, 2024 - FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review
• November 5, 2024 - FDA Roundup
• November 4, 2024 - FDA Pilot to Gain Experience Reviewing a Small Number of Original Applications following Split Real Time Application Review (STAR) Paradigm
• November 4, 2024 - FDA and EPA Announce First Registered Pre-Harvest Agricultural Water Treatment
• November 4, 2024 - FDA Releases Supplement to the 2022 Food Code
• October 31, 2024 - FDA approves REMS modification, advancing new drug disposal option

Spotlight!

FDA in Your Day

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.

Interested in Public Health?  Become a Consumer Representative Member on an FDA Advisory Committee

We’re recruiting!  FDA is seeking individuals with expertise in their field and experience representing the consumer perspective to serve as consumer representatives on our advisory committees.  Consumer representatives collaborate with leading experts to evaluate scientific data, discuss benefits and risks, and provide external, independent advice to FDA that the Agency considers as part of our regulatory decision-making.  Consumer representatives bring a unique perspective to advisory committee discussions and help ensure that consumer interests are represented.

For additional information, please click here!  We look forward to hearing from you soon.

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.

Guidance Documents

CPG Sec 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24)

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.

View all Official FDA Guidance Documents and other Regulatory Guidance

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.

Webinars and Virtual Workshops

Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age

November 15, 2024; 9 a.m. - 4 p.m. ET

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.

FDA Oncology Center of Excellence Presents: Conversations on Cancer - Pediatric Cancers: Navigating the Challenges Together

November 19, 2024; 9:30 a.m. - 10:30 a.m. ET

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.

Public Meeting on the Recommendations for the Over-the-Counter Monograph Drug User Fee Program (OMUFA) Reauthorization - 11/20/2024

November 20, 2024; 9 a.m. - 12:30 p.m. ET

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.

M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance

November 21, 2024; 1 - 3 p.m. ET

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.

View Upcoming FDA Meetings, Conferences and Workshops

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.