November 2, 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 Office of Public Engagement

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:

• Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG (PF4-H)
• Nova Biomedical Updates Use Instructions for StatStrip Glucose Meters
• Early Alert: Medline Removes or Corrects All Medline Brand Beds and Accessories 
• Early Alert: B. Braun Removes Streamline Bloodline Set for Dialog+
• Ultimate Forza Male Supplement by Tonight We Ride: Recall - Due to Presence of Undeclared Sildenafil, Tadalafil, and Dapoxetine

Updates

• Oct. 30, 2026 - FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis
• Oct. 30, 2026 - FDA Advises Consumers Not to Buy or Serve Once Upon a Farm Tractor Wheels Organic Toddler Soft-Baked Bars
• Oct. 30, 2026 - Menopausal Hormone Therapies with Updated Prescribing Information
• Oct. 30, 2026 - FDA Authorizes Marketing of 24 Velo Nicotine Pouches
• Oct. 29, 2026 - FDA’s Infant Formula Product Testing Results
• Oct. 29, 2026 - Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations
• Oct. 29, 2026 - Update to the Frequently Asked Questions Regarding the FDA Food Allergen Labeling Guidance for Industry - Web Page Update
• Oct. 29, 2026 - Adoption of the FDA Food Code by State and Territorial Agencies Responsible for the Oversight of Restaurants and/or Retail Food Stores
• Oct. 28, 2026 - CDRH Learn
• Oct. 28, 2026 - FDA and EMA Discuss Collaboration on Herbal / Botanical Drug Products
• Oct. 27, 2026 - FDA and CMS Announce New Steps to Advance Gene Therapies and Expand Access for Patients with Rare Diseases  
• Oct. 26, 2026 - FDA Approves Talazoparib with Enzalutamide for Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer with HRR Gene Mutations
• Oct. 26, 2026 - FDA Advisory: Do Not Feed Two Lots of Darwin’s Natural Pet Products Chicken Recipe Cat Food Due to Salmonella

Spotlight

Infant Formula Notice of Proposed Rulemaking Infant Formula Nutrient Requirements

The proposed rule represents the first phase of a comprehensive review of the nutrients required in infant formula marketed in the United States.  The FDA is conducting the review in three phases, focusing in this first phase on eight nutrients.  Subsequent phases will assess the remaining required nutrients, potential new nutrient requirements, and carbohydrate sources.  The FDA intends to consolidate all changes to infant formula nutrient requirements into a single comprehensive final rule.

Guidance Documents

• E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers (R1)
• Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products
• Electronic Submission Template for Investigational Device Exemption (IDE) Applications
• Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management

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 Public Meeting - Challenges and Solutions in Lot-Level Food Traceability

Date: Friday, November 6, 2026; noon- 3 p.m. ET

The FDA is hosting a virtual public meeting on November 6, 2026, to give the public an opportunity to share information on implementation of the Food Traceability Rule and areas of remaining concern, specifically as they relate to lot-level tracking and potential flexibilities for compliance.

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

About Us

The Office of Public Engagement resides within the Office of the Commissioner and falls under the Office of Public 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.