October 28, 2024

Dear Public Engagement 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

• October 25, 2024 - FDA Roundup
• October 25, 2024 - Outbreak Investigation of E. coli O157:H7: McDonald’s Quarter Pounders (October 24)
• October 24, 2024 - FDA Approves New Treatment for Allergic Skin Conditions in Dogs
• October 22, 2024 - Science and Research | Medical Devices | FDA
• October 22, 2024 - $76 Million in Illegal E-Cigarettes Seized in Joint Federal Operation
• October 21, 2024 - FDA Partners with Purdue University and Indiana Agricultural Stakeholders on Multi-year Environmental Microbiological Study to Enhance Food Safety

Spotlight!

FDA in Your Day

Here’s a quick update on the at-home testing options available for respiratory illness. For COVID-19, each U.S. household may order up to four tests at no charge. If you haven’t already, go to COVIDTests.gov to order yours today.

Consumer Updates

Help the FDA Prevent the Sale of Tobacco Products to Young People

While overall smoking rates have declined over the years, youth tobacco use remains a concern. According to the National Youth Tobacco Survey, in 2024 about 2.25 million youth reported current use of any tobacco product, including more than 1.63 million youth who reported current use of e-cigarettes.

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.

Guidance Documents

Drug Interaction Information in Human Prescription Drug and Biological Product Labeling

This guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of drug interaction (DI) information in labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products.

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

This guidance explains how FDA incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter).

Postoperative Nausea and Vomiting: Developing Drugs for Prevention

This guidance provides recommendations regarding the design of clinical trials for the prevention of postoperative nausea and vomiting in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.

Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method

The purpose of this guidance is to provide recommendations on the development of blood collection, processing, and storage systems (e.g., blood bags with anticoagulant and additive solutions, empty bags for platelet pooling) intended for the manufacture of blood and blood components for transfusion using the buffy coat (BC) method.  This guidance is intended for manufacturers of blood collection, processing, and storage systems.

Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

The purpose of this guidance is to provide a framework for considering whether and what type of long-term neurologic, sensory and developmental evaluations could be useful to support a determination of safety of a drug, biological product, or device (referred to as ‘medical product’ in this guidance) for use in neonates, and if so, which domains of neurodevelopment may be most applicable.

Core Patient-Reported Outcomes in Cancer Clinical Trials

This guidance provides recommendations to sponsors for collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. Although this guidance focuses on patient-reported outcome (PRO) measures, some of these recommendations may be relevant to other clinical outcome assessments (i.e., clinician-reported outcome, observer-reported outcome, performance outcome) in cancer clinical trials.

Requests for Reconsideration at the Division Level Under GDUFA

This guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.  This guidance reflects the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III) and clarifies what matters are appropriate for requests for reconsideration.

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.

Webinars and Virtual Workshops

Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A

October 30, 2024; 1 - 2:30 p.m. ET

Join the FDA on October 30, 2024, for the Medical Device Sterilization Town Hall: Short Topics and Open Q&A. During this town hall, we will discuss submitted questions and comments, activities to support medical device innovators, and bundling sterility submissions. We will also host an open question-and-answer session.

Registration is not necessary

Opportunities to Improve Dose-Finding and Optimization for Rare Disease Drug Development

October 29, 2024; 10 a.m. - 3:30 p.m. ET

The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the FDA is convening a one-day public virtual workshop focused on sharing effective strategies for dose-finding and optimization in rare diseases and best practices for early-phase trial design.

Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation

November 7, 2024; 1 - 2:30 p.m. ET

This webinar aims to inform stakeholders, particularly those who design, implement and assess risk evaluation and mitigation strategies (REMS), on the recently published guidance REMS Logic Model: A Framework to Link Program Design With Assessment.

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.

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.