November 18, 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 15, 2024 - Audio Transcript | The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball
• November 15, 2024 - FDA Roundup
• November 15, 2024 - Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies (June 2024)
• November 14, 2024 - FDA Approves First Generic Florfenicol for Controlling Mortality in Freshwater-reared Fish
• November 14, 2024 - FDA Approves First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency
• November 14, 2024 - Preparing for the Next Pandemic: Lessons Learned and the Path Forward
• November 14, 2024 - Advancing alternative methods to reduce animal testing
  

Spotlight!

More Information on Recalls | FDA in Your Day

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.

Consumer Update

Know When and How to Use Antibiotics, and When to Skip Them

Antibiotics are powerful medications that save countless lives every day. But they’re not the answer for every illness.

Antibiotics treat only some infections caused by bacteria – and none caused by viruses. Most often, antibiotics work by killing the targeted bacteria or by making it difficult for the bacteria to multiply.

Talk to your health care professional about the best treatment for you when you are sick. The U.S. Food and Drug Administration encourages taking all medications, including antibiotics, as directed by your health care professional.

Guidance Documents

Guidance for Industry: FDA's Voluntary Qualified Importer Program

This guidance document describes FDA’s policy regarding participation in FDA’s Voluntary Qualified Importer Program (VQIP) by importers of food for humans or animals.  This document provides guidance on:

• The benefits VQIP importers can expect to receive;
• The eligibility criteria for VQIP participation;
• Instructions for completing a VQIP application;
• Conditions that may result in revocation of participation in VQIP; and
• Criteria for VQIP reinstatement following revocation.

This guidance document is presented in question and answer format.  This guidance document may be modified (in accordance with FDA’s good guidance practice regulation (21 CFR 10.115)) as VQIP is implemented and evaluated.

Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics

The FDA is announcing the availability of a draft guidance for industry entitled “Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics.”  FDA is publishing this draft guidance which, when finalized, will provide recommendations on approaches for the nonclinical safety evaluation of oligonucleotide-based therapeutics (ONTs) to support clinical development and marketing of these products.

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!

Understanding Drug Recalls - "Q&A with FDA"

Welcome to “Q&A with FDA.” In this podcast series, we aim to answer some of the most frequently asked questions that we’ve received from the public.   Today we are joined by Dr. Ileana Elder, Branch Chief in the Incidents, Recalls, and Shortages Branch within the Office of Compliance in FDA’s Center for Drug Evaluation and Research.

Webinars and Virtual Workshops

Webinar – Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs)

December 3, 2024; 1 - 2 p.m. ET

On December 3, 2024, the FDA will host a webinar to provide information on how to comply with registration and listing requirements for IVDs, including LDTs. 

Registration is not required

Navigating the Transition to Low Global Warming Potential Propellants

December 4 - 5, 2024

Day 1: Wed, Dec 4; 8:30 a.m. - 5:30 p.m. ET
Day 2: Thu, Dec 5; 8:30 a.m. - 5:30 p.m. ET

The purpose of this two-day workshop is to engage subject matter experts from academia, brand name and generic drug industries, and health and regulatory agencies to discuss the current scientific understanding of LGWP propellants and the challenges encountered by the drug industry as they advance their transition development programs. This workshop will also cover the scientific and regulatory considerations regarding the data requirements to support an MDI transition program for both brand name and generic drugs.

Clinical Pharmacology Considerations for Novel Therapeutic Modalities

December 4, 2024; 1 - 3 p.m. ET

This webinar will discuss the clinical pharmacology considerations for the development of novel therapeutic modalities. To support the growing number of novel therapeutics, the final guidances on oligonucleotide therapeutics and antibody-drug conjugates will be highlighted and described in detail.

FDA Clinical Investigator Training Course (CITC) 2024

December 10 - 12, 2024

Day 1: Tue, Dec 10; 11 a.m. - 3:30 p.m. ET
Day 2: Wed, Dec 11; 11 a.m. - 4 p.m. ET
Day 3:  Thu, Dec 12; 11 a.m. - 3:05 p.m. ET

The primary goal of this clinical investigator training course is to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. The course aims to prepare clinical investigators to conduct high-quality research that contributes to scientific knowledge and improves patient care.

Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products – Looking Forward

December 12, 2024; 12:30 p.m. - 5:00 p.m. ET

Today, the U.S. Food and Drug Administration is announcing a free public workshop that will focus on recent accomplishments, ongoing opportunities & challenges, and forward-looking initiatives regarding FDA’s Real-World Evidence Program for drugs and biological products. 

This public workshop will discuss potential next steps to promote the continued evolution and consistent application of real-world data in drug development. The public workshop will be convened and supported by a cooperative agreement between FDA and the Duke-Margolis Institute for Health Policy at Duke University. 
Please register by Friday, December 6, 2024. Registration is free and based on available space due to limited seating. Early registrants will have priority.

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.