July 27, 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: Percutaneous Catheter Issue from Boston Scientific
• Cyclophosphamide for Injection, USP to the User Level by Sunny Pharmtech
• Cetirizine Hydrochloride Tablets USP 5 mg by Unique Pharmaceutical Laboratories
• Early Alert: Intravascular Administration Set Issue from Baxter

Updates

• July 24, 2026 - FDA Approves Zidesamtinib for ROS1-Positive Non-Small Cell Lung Cancer
• July 24, 2026 - Outbreak Investigation of Salmonella: Eggs (July 2026)
• July 24, 2026 - Investigation of 9-State Outbreak of Cyclospora Illnesses: Iceberg Lettuce (July 2026)
• July 24, 2026 - FDA Approves First Nonprescription Fixed-Dose Combination of Acetaminophen and Naproxen Sodium for 12-Hour Pain Relief
• July 22, 2026 - FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
• July 22, 2026 - Outbreak Investigation of Salmonella: Moringa Leaf Powder (January 2026)
• July 22, 2026 - FDA Releases National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan for 2026 - 2030
• July 22, 2026 - FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
• July 21, 2026 - FDA Launches Pilot Program to Incentivize Manufacturing of Animal Drug Products in the U.S.
• July 21, 2026 - FDA Announces Funding Opportunity for Digital Health Technologies
• July 20, 2026 - FDA Advises Human and Animal Food Facilities to Protect their Food Facility Registration Information

Spotlight

Public Meeting on Listeria monocytogenes Prevention

The FDA is hosting a public meeting on August 18-19, 2026, on Listeria monocytogenes prevention.  This meeting will be the first in a series of public engagements, including workshops and webinars, to discuss best practices for managing risks posed by Listeria monocytogenes (L. monocytogenes).  These discussions will highlight the perspectives of individual stakeholders and complement the agency's efforts to integrate the latest scientific advancements and emerging developments in the prevention of L. monocytogenes.

Guidance Documents

• Hemodialysis Blood Tubing Sets - Premarket Notification (510(k)) Submissions

View all Official FDA Guidance Documents and other Regulatory Guidance
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 Virtual Workshops

FDA/Health and Environmental Sciences Institute/Safety Pharmacology Society Hybrid Workshop: ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology

Date: Tuesday, July 28, 2026; 8:30 a.m. - 4 p.m. ET

The US FDA in collaboration with the Health and Environmental Sciences Institute (HESI), and the Safety Pharmacology Society (SPS) will host a hybrid public workshop entitled “ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology” on July 28, 2026.  This one-day meeting aims to unite representatives from regulatory agencies and industry to develop a cohesive vision and scientific rationale for revising the International Council for Harmonisation (ICH) S7A guideline, with the goal of gathering key stakeholder perspectives and building consensus to reopen the guideline.

Cellular, Tissue, and Gene Therapies Advisory Committee July 29, 2026 Meeting Announcement- UPDATED INFORMATION (as of 7/16/2026)

Day 1: Wednesday, July 29, 2026; 9:30 a.m. - 4:50 p.m. ET

Cellular, Tissue, and Gene Therapies Advisory Committee July 30, 2026, Meeting Announcement- UPDATED INFORMATION (as of 7/16/2026)

Day 2: Thursday, July 30, 2026; 9:30 a.m. – 4:50 p.m. ET

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science.  Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.  Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

Accelerating Product Development for Pediatric Systemic Lupus Erythematosus (SLE)

Day 1: Thursday, July 30, 2026; 9 a.m. - 5 p.m. ET
Day 2: Friday, July 31, 2026; 9 a.m. - 12:30 p.m. ET

The U.S. FDA, with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will host a workshop, “Accelerating Product Development for Pediatric Systemic Lupus Erythematosus,” on July 30-31, 2026.  This workshop will examine key similarities and differences between adult and pediatric systemic lupus erythematosus (SLE) and explore opportunities to leverage strategies, including extrapolation and innovative trial designs, to improve the efficiency and feasibility of pediatric SLE studies.  The workshop will foster open dialogue among researchers, clinicians, regulatory authorities, patients and patient advocates, and industry stakeholders to advance therapeutic development for pediatric SLE.

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

Date: Thursday, August 27, 2026; 9:30 a.m. - 3:45 pm 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.

View Upcoming FDA Meetings, Conferences and Workshops
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.