September 8, 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:

• Business Pill and Branch Manager for Men by SUPPLX.com
• 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB Container by B. Braun Medical
• Three Lots of Epinephrine Injection USP, 30 mg/ 30 mL (1 mg/mL) by American Reagent
• Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Leads
• Early Alert: Breathing Circuit Issue from Draeger
• Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software
• Early Alert: Convenience Kit Issue from AVID Medical
• Lipofit Extreme Fat Burner 2.0 by Ana Salazar Modela Tu Cuerpo
• 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB Container by B. Braun Medical

Updates

• Sept. 4, 2026 - FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
• Sept. 4, 2026 - FDA Grants Accelerated Approval to a New Breast Cancer Treatment
• Sept. 3, 2026 - FDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats
• Sept. 3, 2026 - Outbreak Investigation of Salmonella: Eggs (July 2026)
• Sept. 3, 2026 - FDA Update on Estradiol Transdermal Patch Availability
• Sept. 3, 2026 - FDA Seeks Public Input to Advance Development of Botanical Drug Products
• Sept. 1, 2026 - FDA Adds Boxed Warning to Labeling for Ferric Carboxymaltose Injection (Injectafer) to Describe Risk of Low Phosphate Levels
• Sept. 1, 2026 - PFAS in Medical Devices: What You Need to Know
• Aug. 31, 2026 - FDA Approves Treatment for Essential Thrombocythemia
• Aug. 31, 2026 - International Collaboration to Advance New Testing Methods That Reduce Reliance on Horseshoe Crab Blood
• Aug. 31, 2026 - Outbreak Investigation of Shiga Toxin-producing E. coli & Salmonella: Sprouts (August 2026)
• Aug. 31, 2026 - SEC and FDA Announce MOU to Bolster Cooperation and Ensure Market Integrity

Spotlight

FDA Approves First Drug to Treat Alexander Disease

The FDA has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients.  Zanvastro is the first FDA-approved treatment for Alexander disease and the first therapy to directly target the protein buildup that drives the disease.

FDA Voices

Good Clinical Practices Are Not Optional: The FDA’s Commitment to Human Subject Protections and Gold Standard Science in an Era of Global Clinical Research

By: Michael Davis, M.D., Ph.D., Acting Director, Center for Drug Evaluation and Research; Karim Mikhail, B.Pharm, MSc, Acting Director, Center for Biologics Evaluation and Research; Michelle Tarver, M.D., Ph.D., Director, Center for Devices and Radiological Health, R. Angelo de Claro, M. D., Director, Oncology Center of Excellence

For decades, Good Clinical Practice (GCP) has provided the ethical and scientific foundation for clinical investigations submitted to the FDA.  Its purpose is straightforward: establishing a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that helps ensure that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected.  All clinical trials of investigational products submitted to the FDA must comply with GCP.

Guidance Documents

• Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates
• Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions
• Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
• Dental Curing Lights - Premarket Notification (510(k)) Submissions
• CVM GFI #115 (VICH GL22) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)
• CVM GFI #116 (VICH GL23 (R2)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)

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

Addressing the Public Health Effects of Opioid Medications

Date: Wednesday, September 9, 2026; 12:30 - 4:30 p.m. ET

On September 9, 2026, the FDA, in partnership with the Reagan-Udall Foundation for the FDA (Foundation), will convene a hybrid meeting to hear public comments on perspectives regarding the use of opioid medications for the management of pain and addiction.  The meeting will also feature a panel discussion with federal partners to discuss efforts to improve the management of pain and addiction.

Town Hall – Biocompatibility Risk Assessment

Date: Wednesday, Sept. 9, 2026; 1 - 2 p.m. ET

FDA will host a town hall for industry and other interested parties to discuss recent updates to ISO 10993-1(2025), “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” and share risk assessment approaches for evaluating biocompatibility endpoints for medical devices, with specific examples for evaluating material-mediated pyrogenicity and systemic endpoints.

Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products

Date: Thursday, Sept. 10, 2026; 8:30 a.m. - 12:40 p.m. ET

This half-day virtual workshop features FDA expert presentations and audience Q&A on bioequivalence (BE) approaches for topical and transdermal generic drug products.  FDA uses Generic Drug User Fee Amendments (GDUFA)-funded regulatory science and research to develop and revise general and product-specific guidances and to support abbreviated new drug application (ANDA) review.  Case examples will show how research findings have informed guidance recommendations and ANDA assessment.

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.