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 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.
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.
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.
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.
The FDA is announcing the availability of a draft guidance for industry entitled “Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics.” FDA is publishing this draft guidance which, when finalized, will provide recommendations on approaches for the nonclinical safety evaluation of oligonucleotide-based therapeutics (ONTs) to support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.
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.
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.
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.
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.
Day 1: - 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.
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.
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 18, 2024
