November 4, 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 1, 2024 - FDA Roundup
• November 1, 2024 - FDA Warns Patients and Health Care Professionals Not to Use Compounded Drugs from Fullerton Wellness
• November 1, 2024 - FDA Issues Final Compliance Policy Guide for Scombrotoxin (Histamine)-forming Fish and Fishery Products
• November 1, 2024 - FDA Starts Next Phase of Sodium Reduction Efforts
• October 30, 2024 - FDA Human Foods Program: FY 2025 Priority Deliverables
• October 29, 2024 - FDA Update on Phthalates in Food Packaging and Food Contact Applications
• October 29, 2024 - FDA Roundup
• October 28, 2024 - Hurricane Helene: Baxter's manufacturing recovery in North Carolina
• October 25, 2024 - FDA Roundup

Spotlight!

Food Safety for the Holidays!

Big celebrations, cherished traditions, and large family gatherings with all of your favorite dishes make this time of year joyful, but that joy can be short lived if any of the food makes you or your loved ones ill.

At-Home OTC COVID-19 Diagnostic Tests

Holiday celebrations are approaching. With an increase in social gatherings comes the likelihood of an increase in positive COVID-19 cases. Testing helps prevent and contain the spread of COVID-19.

FDA Voices

FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub

By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

This summer, the U.S. Food and Drug Administration announced plans to establish the Rare Disease Innovation Hub (the Hub), and today, we are excited to share more about our progress. The Hub is an FDA cross-center program that will act as the single point of engagement and connection with outside parties for drug and biological product development and as a forum for the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) to collaborate on cross-cutting rare disease-related issues.

Our first major step toward establishing the Hub was to gather feedback from our partners in the rare disease community. In collaboration with the Reagan-Udall Foundation for the FDA, we hosted a public meeting, Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub, on October 16, 2024. The meeting brought together rare disease patient advocates, academic researchers, regulated industry, and others to discuss how the Hub can best engage with members of the community and prioritize its work. There was also a public docket to capture feedback from those unable to speak during the public meeting.

Guidance Documents

M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms

This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies 4 during both development and post approval phases for orally administered immediate-release (IR) 5 solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, 6 capsules, and granules/powders for oral suspension.

Guidance for Industry: Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination

FDA is issuing this guidance to help tattoo ink manufacturers and distributors recognize situations in which a tattoo ink may become contaminated with microorganisms, and thus, be potentially injurious to health. This guidance also recommends certain steps that manufacturers and distributors could take to help prevent the occurrence of these conditions, or to identify and remediate insanitary conditions that already exist during manufacturing and distribution.

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!

FDA’s Critical Role in Ensuring Safe and Effective Flu Vaccines

The flu (influenza) vaccine you get at your doctor’s office or pharmacy is the result of year-round work of highly skilled microbiologists, epidemiologists, physicians and other public health experts.

Sound complicated? It is.

Webinars and Virtual Workshops

Informed Consent – More than Just Another Document to Sign?

November 8, 2024; 2 - 3 p.m. ET

This webinar will provide patients and researchers with an overview of FDA’s expectations for informed consent. The webinar will:

• Give an update on FDA’s efforts to help improve informed consent materials so that they are more understandable for participants;
• Recommend how informed consent can be presented in a clear, comprehensible way; and
• Discuss how revised consent can help individuals make an informed decision on whether to join a clinical trial.

Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies

November 12, 2024; 11 a.m. - Noon ET

This webinar will discuss the final guidance for the industry Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies which was published in July 2024. This guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drugs.

Workshop on Integration Site Analysis During Long Term Follow-Up for Gene Therapies with Integrating Viral Vectors

November 14, 2024; 9:30 a.m. - 5 p.m. ET

In this workshop, the FDA will convene a panel of external experts to discuss the risk of insertional mutagenesis and best practices for ISA method design, data analysis, and clinical interpretation.

FDA Grand Rounds – Synthetic Data for Medical Imaging AI

November 14, 2024; Noon - 1 p.m. ET

This webinar will:

1. Analyze different classes of techniques for generating synthetic medical imaging data and recognize their strengths and weaknesses.
2. Identify how synthetic data can be used in various stages of the AI lifecycle.

FDA employees MUST register in BOTH the following:

Non-FDA employees must register in:

2024 FDA Broad Agency Announcement Day

November 14, 2024; 1 - 4 p.m. ET

FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. 2024 FDA BAA Day will provide an opportunity to the applicants as well as FDA staff to learn more about the application process and FDA’s priorities for regulatory research. Join us to learn more about the research priorities for Fiscal Year 2025 BAA, and how to apply.

Biomarkers and Therapeutics for Women's Cardiovascular Health

November 14, 2024; 3 - 4 p.m. ET

Cardiovascular disease (CVD) is the leading cause of death globally, killing more than 17.9 million people each year. In the U.S., CVD kills more women than all forms of cancer combined, and there are profound sex differences in CVD incidence, progression, and response to treatment. 

Registration is not necessary.

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

The FDA’s Center for Biologics Evaluation and Research (CBER) is excited to host a patient and care partner listening meeting – Patient and Care Partner Perspective on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases on Wednesday, December 4 from 11 a.m. – 4:30 p.m. ET.

The objective of this meeting is to understand what patients, and caregivers of patients in the pre-symptomatic or early stages of disease take into consideration when deciding whether to enroll in a gene therapy clinical trial and potentially receive an investigational gene therapy product.

The meeting will be divided into two sessions and patients, advocates, and caregivers are encouraged to request to speak during the registration process. The deadline to request to speak is Tuesday, November 5.

Please join us for this patient-focused event:

• Date: December 4, 2024
• Time: 11a.m. – 4:30 p.m. ET
• Location: This is a virtual public listening meeting and will be held via Zoom.
• Registration: This meeting is free and open to the public; however, registration is required. Early registration is recommended.

Registration to attend will close on Tuesday, December 3, at 11:59 p.m. ET. A recording and other relevant meeting materials will be posted online following the event. Registration to request to speak or present will close on November 4, at 11:59 p.m. ET.

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.