December 2, 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 26, 2024 – Healthcare Providers’ Use of a Concise Summary to Prescribe for Lactating Patients
• November 26, 2024 - FDA Roundup
• November 25, 2024 – FDA Approves Drug for Heart Disorder caused by transthyretin-mediated amyloidosis
• November 21, 2024 - F&S Fresh Foods Recalls Whole Foods Market Organic Carrot Sticks and Organic Carrots & Celery Because of Possible Health Risk Due to Potential E. coli Contamination

Webinars and Virtual Workshops

Medical Device Sterilization Town Hall: Sterilization Short Topics, Series Impact, Wrap Up, and Next Steps

December 4, 2024; 2 - 3:30 p.m. ET

Join the FDA on December 4, 2024, for the Medical Device Sterilization Town Hall: Sterilization Short Topics, Series Impact, Wrap Up, and Next Steps.

During this town hall, we will discuss two short topics, including the new Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices Guidance, and research and modeling on diffusion of vaporized hydrogen peroxide (VH202) through select polymeric materials. We will also discuss the town hall series impact, as well as wrap up the series and explore next steps.

Registration is not necessary.

Clinicians Connect: Conversations with FDA’s Chief Medical Officer on reducing the cases of congenital syphilis and syphilis

December 4, 2024; 1 - 2 p.m. ET

Clinicians will hear directly from the FDA, CDC, HHS, and NIH about what we can do to address the recent surge in syphilis and its impact on individuals, pregnant people and babies.

Navigating the Transition to Low Global Warming Potential Propellants

December 4 - 5, 2024

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

Meeting 2: Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases

December 4, 2024; 11:00 a.m. - 4:30 p.m. ET

The FDA Center for Biologics Evaluation and Research (CBER) is hosting a public patient listening meeting and opening a docket to better understand patient and care partner perspectives on enrollment of rare disease patients into gene therapy clinical trials in the pre-symptomatic or early symptomatic stages of their disease.

Guidance Documents

Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices

FDA is issuing this guidance to communicate its policy regarding sterilization site changes for ethylene oxide (EtO) sterilized PMA and HDE devices in situations where those devices are affected by the potential, actual, or temporary operation reductions at sterilization facilities that may affect the availability of those sterile medical devices.

Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products

This draft guidance provides recommendations to sponsors regarding the measurement of ovarian toxicity using clinical measures and biomarkers of ovarian function in relevant cancer clinical trials that enroll premenopausal adults with ovaries.

Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects

The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled “Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects.” This draft guidance makes recommendations on followup testing for Ames-positive active ingredients in circumstances when a sponsor decides to continue development. The guidance recommends a consistent process of followup testing and evaluation that first should be conducted for an Ames-positive active ingredient before proceeding with first-in-human (FIH) trials in healthy human subjects.

Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; Availability

This guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor DNA (ctDNA) as a biomarker in cancer clinical trials conducted under an investigational new drug application (IND) and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage (curative-intent) setting.  This guidance reflects FDA’s current thinking regarding drug development and clinical trial design issues related to the use of ctDNA as a biomarker in clinical trials for solid tumor malignancies in the curative-intent setting.

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!

Safe Food Handling

The food supply in the United States is among the safest in the world. However, when certain disease-causing bacteria or pathogens contaminate food, they can cause foodborne illness, often called “food poisoning.” The Federal government estimates that there are about 48 million cases of foodborne illness annually – the equivalent of sickening 1 in 6 Americans each year. And each year, these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths.

Upholding Public Trust: FDA Office of Criminal Investigations’ Crucial Role in Bringing Drug Criminals to Justice

By: Justin D. Green, MBA, MDiv., Assistant Commissioner, FDA Office of Criminal Investigations

A few significant ways the FDA protects public health is through facilitating product recalls or market withdrawals and issuing safety alerts. But when bad actors circumvent the system, the FDA Office of Criminal Investigations (OCI) enters the scene to ensure the safety of American food, medical products, and other FDA-regulated products. Partners are essential to OCI's ability to meet its mission and can include local and state police, federal law enforcement agencies like the Department of Homeland Security’s Customs and Border Protection and Homeland Security Investigations, the Drug Enforcement Administration, the Department of Justice, the U.S. Postal Inspection Service, and foreign governments. Whether it's circumventing the FDA regulatory process, distributing counterfeit or misbranded prescription drugs or other FDA-regulated medical products, engaging in illegal diversion of prescription drugs, selling fraudulent products with claims to prevent, treat, or cure diseases, or jeopardizing patient safety, OCI works closely with jurisdictional and regulatory partners to investigate crimes and protect public health.

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.