August 24, 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:

• Early Alert: Convenience Kit Issue from AVID Medical 
• Early Alert: Convenience Kit Issue from Medline
• Early Alert: Portrait Core Services Software Issue from GE HealthCare
• Early Alert: Breathing Circuit Issue from Medline 
• Early Alert: Epidural Kit Issue from Medical Action Industries
• Medline Issues Correction for Convenience Kits Containing B. Braun Bupivacaine Hydrochloride Components
• Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials by Optimal Balance Pharmacy
• Excel Lactated Ringers Injection, 1000 mL by B. Braun Medical
• Early Alert: Convenience Kit Issue from Becton Dickinson
• Schwarzkopf Professional Osis Grip 6.76 fl. oz / 200 mL by Henkel Corp.

Updates

• Aug. 21, 2026 - Outbreak Investigation of Shiga Toxin-producing E. coli & Salmonella: Sprouts (August 2026)
• Aug. 21, 2026 - Participants Selected for TEMPO for Digital Health Devices Pilot
• Aug. 21, 2026 - FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development
• Aug. 21, 2026 - FDA Authorizes 11 New Nicotine Pouches
• Aug. 20, 2026 - Collaborating on Food Safety Culture
• Aug. 19, 2026 - FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia
• Aug. 19, 2026 - Outbreak Investigation of Salmonella: Jalapeño (August 2026)
• Aug. 19, 2026 - FDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device
• Aug. 19, 2026 - FDA Approves Second Treatment for Fibrodysplasia Ossificans Progressiva
• Aug. 18, 2026 - FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

Spotlight

FDA Public Meeting: Testosterone Use In Menopausal Women

The purpose of the workshop is to examine the current scientific evidence and critical knowledge gaps related to testosterone use in menopausal women to help inform future research and potential drug development in this area.

FDA Voices

FDA Weighs in on the Development and Use of Digitally Derived Measures for Clinical Investigations

By: Rick Abramson, M.D., Director, Digital Health Center of Excellence

Guidance Documents

• Evaluation of Therapeutic Equivalence
• Potency Assessment of Active Immunotherapy Products
• Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products
• Determining Whether to Submit an ANDA or a 505(b)(2) Application

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 Public Meeting: FDA-Led Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds

Date: Tuesday, Aug. 25, 2026; 10 a.m. - 4:30 p.m. ET

On August 25, 2026, the U.S. FDA is hosting a hybrid public meeting on Patient-Focused Drug Development for Nonhealing Chronic Wounds.  This meeting will provide FDA and other key stakeholders, including medical product developers, health care providers, and academic researchers, the opportunity to hear directly from patients, patient representatives, and care partners about their experiences with nonhealing chronic wounds, including how the wounds and associated wound care affect their daily life, what matters most to them, their current approaches for managing or treating their nonhealing chronic wounds, and what they consider when determining whether to participate in a clinical trial.

Advancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs

Date: Thursday, Aug. 27, 2026; 8:30 a.m. - 12:30 p.m. ET

This half-day workshop includes a series of expert-lead presentations and audience Q&A sessions focused on the latest advancements and regulatory considerations in the evolving field of Model-Integrated Evidence (MIE)-supported generic drug development and approval.  Attendees at this workshop will gain valuable insights into FDA's regulatory expectations for MIE submissions, learn practical strategies for avoiding common pitfalls, and hear real-world case studies demonstrating how MIE has successfully supported FDA guidance development and generic drug approvals.

FDA Virtual Workshop on Digital Health Technologies and Statistical Considerations for Digitally-Derived Endpoints in Clinical Trials

Date: Thursday, Aug. 27, 2026; 9:30 a.m. - 3:45 p.m. ET

The FDA is hosting a free virtual public workshop, convened by the Duke-Margolis Institute for Health Policy under a cooperative agreement with the FDA, to discuss statistical considerations for digitally-derived endpoints in clinical trials for drug and biological products.  Speakers will provide updates on FDA efforts under PDUFA VII to advance the use of digital health technologies (DHTs) in drug development and regulatory review.  Discussions will also explore opportunities to strengthen data standards and innovative analytical methods that support the broader use of clinically meaningful, digitally-derived endpoints in clinical trials for drug and biological products.  Speakers will also discuss the Submitting Continuous Glucose Monitoring Data in Clinical Trials Technical Specifications Document to provide foundational background for regulatory submissions for drug and biological product evaluation, device performance assessment, and analytical best practices.

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.