September 21, 2026

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

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:

• Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules
• X10 Natural Enhancement Supplement by A&P Creations
• biQ-FEL by A&P Creations

Updates

• Sept. 18, 2026 - FDA Approves Therapy to Treat Ataxia in Patients with Ataxia-Telangiectasia, a Rare Genetic Disorder
• Sept. 18, 2026 - FDA Approves Imlunestrant in Combination with Abemaciclib for ER-positive, HER2-negative, ESR1-mutated Advanced or Metastatic Breast Cancer
• Sept. 17, 2026 - Food Code 2026
• Sept. 17, 2026 - FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
• Sept. 17, 2026 - FDA Issues Warning About Certain Products Containing Toxic Yellow Oleander
• Sept. 17, 2026 - FDA Issued a Draft Strategy Document BsUFA III Future Needs for the Development of Interchangeable Products 
• Sept. 16, 2026 - Applying for Membership on FDA Advisory Committees
• Sept. 16, 2026 - FDA Releases Report on Food Safety Risk Factors in Retail Delis
• Sept. 16, 2026 - Retail Food Risk Factor Study
• Sept. 15, 2026 - FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use
• Sept. 15, 2026 - FDA Launches Expedited IND Pilot, Begins Accepting Applications
• Sept. 14, 2026 - CDRH Patient Education Program Course 2 Video: Patient-Generated and Real-World Data Throughout the Medical Device Life Cycle

Spotlight

FDA Grand Rounds – CURE ID and FDA’s Drug Repurposing Efforts

This lecture will discuss the CURE ID website and mobile app, and how it can serve as an important real-world data tool to help identify treatments for diseases that don’t have good, approved treatment options.  The speakers will situate CURE ID in the context of the broader FDA repurposing initiatives that are ongoing.

Consumer Updates

The Facts on Tampons and Tampon Safety

If you use tampons during your period, it’s important to know how to use them safely, and to understand how the FDA evaluates their safety and effectiveness.

FDA Voices

An America First Approach to Medical Innovation

By: Kyle Diamantas, J.D., Acting Commissioner of Food and Drugs; Karim Mikhail, B.Pharm, MSc, Director, Center for Biologics Evaluation and Research; and, Michael Davis, M.D., Ph.D., Director, Center for Drug Evaluation and Research

America has long been the world’s premier destination for medical innovation.  Our universities make groundbreaking discoveries.  Our biotechnology companies turn them into medicines.  Our capital markets finance risks few other countries can match.  And the FDA ensures patient safety and efficacy.  This leadership can’t be taken for granted.

Guidance Documents

• Electronic Submission Template for Premarket Approval Applications (PMA)
• CVM GFI #298 (VICH GL62) – Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products
• Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method

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 Workshops

FDA/Center for Research on Complex Generics (CRCG) Workshop on Navigating the GLP-1 Generic Drug Pathway

Day 1: Wednesday, Sept. 23, 2026; 8 a.m. - 4:30 p.m. ET
Day 2: Thursday, Sept. 24, 2026; 8 a.m. - 4:30 p.m. ET

This 2-day workshop will address some of the key product development and regulatory assessment considerations for generic glucagon-like peptide-1 (GLP-1) agonist products.  The goal of this workshop is to provide clarity and foster discussions on evidence-based approaches to establish the acceptable critical quality attributes of recombinant and synthetic generic peptide products, address manufacturing quality considerations, and tackle the unique challenges associated with drug-device combination products, where applicable.

2026 DIA/FDA Oligonucleotide-Based Therapeutics Conference

Day 1: Wednesday, Sept. 23, 2026; 8:15 a.m. - 6:15 p.m. ET
Day 2: Thursday, Sept. 24, 2026; 8 a.m. - 5:15 p.m. ET
Day 3: Friday, Sept. 25, 2026; 7:45 a.m. - 12:45 p.m. ET

The FDA and DIA have expressed a willingness to leverage their combined strengths for the joint development of this conference that will incorporate dialogue between regulators and industry from Chemistry Manufacturing and Controls (CMC), Nonclinical, Clinical Pharmacology, and Clinical disciplines to address the developmental advances, safety, and challenges in the field of oligonucleotide-based therapeutics.  The 2026 Conference will address quality risk management, manufacturing advances, specifications, formulation issues, CMC strategies, oligonucleotide pharmacokinetics, nonclinical assessments in support of drug development and clinical advances in therapeutic targets, trial design and safety for antisense, siRNA, mRNA, and microRNA therapies.  Of special interest, emerging content for the Draft ICH S13 Guidance will be discussed.

Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting Announcement

Date: Wednesday, Sept. 23, 2026; 9 a.m. - 6 p.m. ET

The FDA announces a forthcoming hybrid (in-person and virtual) meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (the Committee).  The general function of the Committee is to provide advice and recommendations to the FDA.

Town Hall – Biocompatibility and Chemical Characterization Testing - Extractions

Date: Wednesday, Sept. 23, 2026; 1 - 2 p.m. ET

The FDA will host a town hall for industry and other interested parties to discuss chemical characterization testing methodology to address biocompatibility endpoints for medical devices.  Specifically, this town hall will focus on approaches for conducting extractions for chemical characterization testing per ISO 10993-18 and share common issues and examples.

Communicating Drug Interaction and QTc Information in the U.S. Prescribing Information

Date: Wednesday, Sept. 23, 2026; 1 - 3 p.m. ET

The first session of this webinar will discuss the draft guidance for industry: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (October 2024).  The second session of this webinar will discuss the guidance for industry: QTc Information in Human Prescription Drug and Biological Product Labeling (December 2025).

Regulatory Perspectives on Herbal Medicinal/Botanical Drug Product Development – Joint FDA/EMA Workshop - 09/25/2026 | FDA

Date: Friday, Sept. 25, 2026; 4 - 7 a.m. ET

Public interest in the therapeutic potential of herbal medicinal/botanical drug products continues to grow, driving increased efforts to develop such products as regulated medicinal products.  Recognizing both the promise of these complex products and the unique challenges they pose, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have existing guidance to facilitate their development.  While both regulators share core principles, there are meaningful differences in their respective regulatory frameworks.

Regulatory Science Innovations Catalyzing Medical Device Development

Date: Friday, Sept. 25, 2026; 8:30 a.m. - 4:30 p.m. ET

The FDA is announcing a public meeting entitled “Regulatory Science Innovations Catalyzing Medical Device Development.”  This meeting is co-sponsored with the Medical Device Innovation Consortium (MDIC).  In conjunction with this meeting, the FDA is opening a docket to receive comments from the public.

Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

ICYMI!

Phase 1 Investigational New Drug (IND) Navigator

The Phase 1 IND Navigator provides the tools, guidances, and regulatory expertise you need to prepare and submit an Investigational New Drug application (IND) to FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

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.