December 8, 2025

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.  Your partnership, knowledge and engagement in the public health space are appreciated.

Sincerely,

The Public Engagement Staff
Public Engagement Staff | FDA

Updates

• December 5, 2025 - FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand Access to Chronic Disease Technologies
• December 5, 2025 - FDA Releases Annual Summary of Sales and Distribution of Antimicrobials in 2024 for Use in Food-Producing Animals
• December 4, 2025 - Outbreak Investigation of Listeria monocytogenes: Ready-to-Eat Foods (May 2025)
• December 4, 2025 - Outbreak Investigation of Salmonella: Moringa Leaf Powder (October 2025)
• December 4, 2025 - FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US
• December 4, 2025 - FDA Conditionally Approves Topical Drug for Cattle for New World Screwworm and Cattle Fever Tick
• December 4, 2025 - Product-Specific Guidances for Generic Drug Development
• December 4, 2025 - Rare Disease Endpoint Advancement Pilot Program
• December 3, 2025 - FDA Announces Leadership Appointments at Center for Drug Evaluation and Research
• December 3, 2025 - FDA Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity
• December 3, 2025 - Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
• December 3, 2025 - Investigations of Foodborne Illness Outbreaks
• December 3, 2025 - FDA Grants Traditional Approval to Pirtobrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
• December 3, 2025 - FDA Launches Web-Based Tobacco Premarket Application Forms to Enhance Submission Process
• December 3, 2025 - FDA Issues Warning About Imported Cookware That May Leach Lead: August 2025
• December 2, 2025 - Fraudulent Products
• December 2, 2025 - Certain Bodybuilding Products Put Consumers at Risk for Heart Attack, Stroke, Serious Liver Damage and More
• December 2, 2025 - FDA Warns about Heavy Metal Poisoning Associated with Certain Unapproved Ayurvedic Drug Products
• December 2, 2025 - Accelerating Rare Disease Cures (ARC) Program Year Three Annual Report
• December 2, 2025 - FDA Seizes 7-OH Opioids to Protect American Consumers
• December 2, 2025 - What Japan is Doing to Encourage Drug Product Submissions: An Interview with MHLW’s Dr. Sato and PMDA’s Dr. Fujiwara
• December 2, 2025 - FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies
• December 1, 2025 - FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment
• December 1, 2025 - Global Generic Drug Affairs- FDA and Health Canada Collaborate on Generic Drug Information Sharing Initiative: Notice

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

The FDA’s medical product safety reporting program for health professionals, patients and consumers, MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products.  The most recent alerts/recalls are here:

• Correction Alert: Olympus Updates Use Instructions for Ligating Device
• Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care

Guidance Documents

• eCopy Program for Medical Device Submissions
• QTc Information in Human Prescription Drug and Biological Product Labeling
• Monoclonal Antibodies: Streamlined Nonclinical Safety Studies

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.

FDA Direct

ICYMI!

Products Containing 7-OH Can Cause Serious Harm

The FDA recommends that consumers avoid 7-OH products, including conventional foods, dietary supplements, and those claiming to treat an ailment or disorder.  While 7-OH occurs naturally in trace amounts in the plant kratom, the FDA’s warning is for products containing 7-OH as an added ingredient or at enhanced levels, which can be dangerous.  7-OH is not approved by the FDA for any medical use and is not lawful as a dietary supplement or when added to conventional foods because it has not met the appropriate safety standard.

Webinars and Virtual Workshops

General Hospital and Personal Use Devices Panel Meeting Announcement

Date: Wednesday, Dec. 10, 2025; 9 a.m. - 3:30 p.m. ET

On December 10, 2025, the Advisory Committee will meet virtually to deliberate and make recommendations on issues related to an emerging technology in the context of medical devices and germicidal ultraviolet (UV) light as a mode of disinfection.  The FDA is seeking to obtain feedback to improve the total product life cycle (TPLC) evaluation of UV disinfection devices.  In addition, the Committee will meet to discuss and provide advice to the FDA on devices used in pandemic preparedness and response to satisfy, in part, a requirement under the Food and Drug Omnibus Reform Act of 2022 (FDORA).

FDA Expert Panel on Testosterone Replacement Therapy for Men

Date: Wednesday, Dec. 10, 2025; 1 - 3 p.m. ET

FDA Expert Panels are roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and individual experts may offer their recommendations for regulatory action.  This initiative is part of the FDA’s broader efforts to apply rigorous, evidence-based standards to modernize regulatory oversight, while considering evolving science and consumer health.  The FDA Expert Panel on Testosterone Replacement Therapy for Men will facilitate discussions on the risks and benefits related to testosterone replacement therapy.

Quality and Regulatory Predictability: Shaping USP Standards

Date: Thursday, Dec. 11, 2025; 9 - 10:30 a.m. ET

This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs.  Attendees will gain insights into the USP standards development process and learn how they can sponsor or participate—via public comment—in the development of future standards.

FDA Oncology Center of Excellence Presents Conversations on Cancer: “Empowered Choices: Perspectives on Cancer Care Decision-Making Among Older Adults”

Date: Thursday, Dec. 11, 2025; 11 a.m. - noon ET

As the global population ages, healthcare providers increasingly encounter unique challenges in tailoring cancer treatments for older patients.  The landscape of cancer care for older adults is complex and multifaceted.  It's where personal values and life experiences intersect with medical expertise and technological capabilities.  The session will explore this intricate tapestry of decision-making in geriatric oncology, emphasizing patient-centered decision-making processes.

FDA Grand Rounds – Advancing Real-World Evidence in FDA Regulatory Decision Making

Date: Thursday, Dec. 11, 2025; noon - 1 p.m. ET

This presentation will explore how the FDA is using real-world data (data routinely collected in clinical practice) to generate real-world evidence (RWE) to inform regulatory decisions about the effectiveness and safety of medical products.  The lecture will cover the evolution of this approach, highlight key activities of the FDA's Real-World Evidence program, and showcase selected guidance documents and demonstration projects that are advancing how we evaluate medical products.

Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine

Date: Tuesday, Dec. 16, 2025; 9 a.m. - 4:30 p.m. ET

This hybrid public workshop will initiate a discussion on expanding epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality.

FDA and The American Society of Pediatric Hematology/Oncology (ASPHO) Pediatric Hematology/Oncology Educational Program

Date: Application Deadline Monday, Dec. 29, 2025, 3 p.m. CT

The FDA and ASPHO have partnered to cosponsor an 8-month interactive educational program designed for early career pediatric hematology/oncology clinicians and researchers.  This program addresses a critical gap in training by providing learners with a foundational understanding of pediatric hematology/oncology drug-development and the regulatory review process.

Cheminformatics Resources of U.S. Governmental Organizations 2026 Workshop

Day 1: Monday, Jan. 5, 2026; 9 a.m. - 4:30 p.m. ET
Day 2: Tuesday, Jan. 6, 2026; 9 a.m. - 4:30 p.m. ET
Day 3: Wednesday, Jan. 7, 2026; 9 a.m. - 4:30 p.m. ET

The purpose of the Cheminformatics Resources of U.S. Governmental Organizations 2026 Workshop is to enhance communication and collaboration between the U.S. Government-funded organizations that create and maintain databases, data standards, datasets, scientific approaches, and computational resources dealing with chemical structures and properties of molecules and materials.

Tobacco Products Scientific Advisory Committee Meeting

Date: Thursday, Jan. 22, 2026; 9 a.m. - 4:30 p.m. ET

Center for Tobacco Products’ TPSAC will meet virtually for an open session, during which the Committee will discuss modified risk tobacco product applications submitted by Swedish Match USA, Inc., for the following products, each available in two strengths (3 milligrams and 6 milligrams).  Discussion will focus on evidence related to the relative health risks of the products, consumer understanding and perceptions of the applicant’s proposed modified risk claim, and the potential public health impact of a modified risk marketing order.

Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks

Day 1: Thursday, Feb. 5, 2026; 1:30 - 5 p.m. ET
Day 2: Friday, Feb. 6, 2026; 8:30 a.m. - 4 p.m. ET

The FDA, in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI), is announcing the following public workshop titled "Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks."  The aim of the public workshop is to discuss common challenges in neonatal and rare disease product development and identify opportunities to leverage rare disease product development frameworks in the neonatal product development space.

Public Meeting: FDA Rare Disease Day 2026

Date: Monday, Feb. 23, 2026; 9 a.m. - 4 p.m. ET

FDA will host Rare Disease Day, a virtual public meeting, on Monday, February 23, 2026, in global observance of Rare Disease Week.  The theme is: “Moving Forward. Looking Ahead. An Event for Patients.”  The goal of this year’s Rare Disease Day is to explore ways to engage and collaborate with patients and their communities to support and accelerate the development of medical products for rare diseases.  We want patients to connect with FDA and stay involved with our outreach and engagement programs to ensure the patient voice informs medical product development and regulation throughout FDA.

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.