September 28, 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: Ventilator Issue from React Health
• Early Alert: Heart Pump Controller Issue from Abiomed
• Niwali Tejocote Capsules and Niwali Tejocote Pieces by Global Mix
• Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection by Par Health
• 0.9% Sodium Chloride Injection, USP by Otsuka ICU Medical

Updates

• Sept. 25, 2026 - FDA Approves Third Treatment for Fibrodysplasia Ossificans Progressiva
• Sept. 25, 2026 - Outbreak Investigation of E. coli O26:H11: Raw Milk Cheese (September 2026)
• Sept. 25, 2026 - FDA Approves Drug to Treat Idiopathic Nephrotic Syndrome in Patients 2 Years and Older
• Sept. 25, 2026 - FDA Publishes Materials from Listeria Public Meeting
• Sept. 24, 2026 - FDA Approves Belzutifan in Combination with Lenvatinib for Advanced Renal Cell Carcinoma with a Clear Cell Component
• Sept. 24, 2026 - FDA Approves Once-Weekly Insulin for Type 2 Diabetes Mellitus
• Sept. 23, 2026 - Federal Court Enters Consent Decree Against Gold Star Distribution, Inc. Following Persistent Insanitary Warehouse Conditions
• Sept. 23, 2026 - FDA Approves Lirafugratinib for Previously Treated, Unresectable, Locally Advanced or Metastatic Cholangiocarcinoma
• Sept. 23, 2026 - FDA Takes Action on New Boxed Warning for Adzynma Enzyme Replacement Therapy for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)
• Sept. 22, 2026 - Warning Letter Empower Clinic Services, LLC dba Empower Pharmacy
• Sept. 21, 2026 - Outbreak Investigation of E. coli O145:H28: Frozen Blueberries (July 2026)
• Sept. 21, 2026 - New Approach Methodologies (NAMs) Database of Use Case Examples
• Sept. 21, 2026 - FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing

Spotlight

New Tobacco Compliance Webinar Series on the SE Predicate Review Process

Guidance Documents

• Robotically-Assisted Surgical Devices - Premarket Submissions

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.

Meetings, Conferences and Workshops

FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates

Date: Tuesday, Sept. 29, 2026; 8:45 a.m. - 4 p.m. ET

Join SBIA as FDA shares the latest updates on registration and listing submissions, including current validation rules, and walks through the evolving regulatory requirements and compliance framework that shape how industry engages with these processes.  We'll also dive into compliance strategies for drug amount reporting requirements — a great opportunity to ask questions and hear directly from those working at the forefront of these issues.

FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing

Date: Tuesday, Sept. 29, 2026; 9 a.m. - 4 p.m. ET

The purpose of the roundtable is to identify supply chain challenges and potential solutions to prevent shortages of supplies and equipment used in blood manufacturing to help ensure a safe and adequate blood supply in the United States.

RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations

Date: Tuesday, Sept. 29, 2026; 9 a.m. - 4:30 p.m. ET

This public workshop, co-convened by Duke Margolis and the FDA Rare Disease Innovation Hub, will explore statistical considerations in the design, conduct, and analysis of clinical investigations for rare disease medical products.

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

ICYMI!

Post-Outbreak Response Activities: Multistate Outbreaks of Cyclospora Illnesses

Food safety doesn’t stop when an outbreak ends.  Following this summer’s multistate Cyclospora outbreaks, FDA is continuing its investigation and working with federal, state, international, industry, academic, and other partners to identify lessons learned and strengthen prevention efforts.  FDA’s new post-outbreak response page will continue to share the latest on these efforts, including key findings, lessons learned, and actions to strengthen prevention.

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.