July 13, 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 Medical Action Industries
• Early Alert: Convenience Kits Issue from Medline
• Infusion Pump Corrections for Ivenix Large Volume Infusion Pumps

Updates

• July 10, 2026 - FDA Proposes Rule to Modernize Drug Manufacturing Registration
• July 10, 2026 - FDA Approves Pembrolizumab or Pembrolizumab and Berahyaluronidase Alfa-pmph each with Enfortumab Vedotin-ejfv for Muscle Invasive Bladder Cancer
• July 10, 2026 - FDA Issued 16 Redacted Complete Response Letters (CRLs)
• July 10, 2026 - FDA Actions to Support and Strengthen Domestic Drug Manufacturing
• July 10, 2026 - FDA Approves Isatuximab-irfc for Subcutaneous Injection for Multiple Myeloma Indications
• July 8, 2026 - FDA Announces Public Meeting on Listeria monocytogenes Prevention
• July 7, 2026 - FDA Shares Recording of Traceability Public Meeting
• July 7, 2026 - FDA Approves New Treatment to Reduce Proteinuria in Adults with Primary Immunoglobulin A Nephropathy
• July 6, 2026 - Outbreak Investigation of E. coli: Frozen Blueberries (July 2026)
• July 6, 2026 - FDA Action: Wilate Indication Expanded to Patients Aged 2 to less than 6

FDA Voices

The FDA at 120: A Long, Distinguished History Protecting Americans

By: Kyle A. Diamantas, J.D., Acting Commissioner of Food and Drugs

Guidance Documents

• Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing

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

ClinicalTrials.gov: Essentials for Academic Medical Centers

Day 1: Tuesday, July 14, 2026; 1 - 2 p.m. ET
Day 2: Wednesday, July 22, 2026; 1 - 2 p.m. ET
Day 3: Thursday, July 30, 2026; 1 - 2 p.m. ET

This virtual training is designed to help staff at academic medical centers meet the federal requirements for registering clinical studies and reporting results on ClinicalTrials.gov.  Specialists from the Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Office of Clinical Policy (OCLP), and the Center for Biologics Evaluation and Research (CBER) within the U.S. Food and Drug Administration (FDA), and the National Library of Medicine (NLM) within the National Institutes of Health (NIH), will address frequently asked questions regarding regulatory obligations and the ClinicalTrials.gov Protocol Registration and Results System (PRS).

Development of Antihypertensive Therapies for Use in Pediatric Patients

Day 1: Wednesday, July 15, 2026; 9 a.m. - 4 p.m. ET
Day 2: Thursday, July 16, 2026; 9 a.m. - noon ET

This FDA public workshop, hosted with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will bring together key stakeholders, including clinicians, academicians, regulators, industry, and patients/caregivers, to discuss the similarities and differences in disease pathophysiology and drug response across age groups, determine the extent to which efficacy can be extrapolated from adults to pediatrics, identify development priorities for both initial therapy and uncontrolled hypertension, and explore feasible strategies to generate evidence for the safe and effective use of antihypertensive treatment(s) in pediatric patients with hypertension, including children younger than six years of age.

View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

ICYMI!

Major Enforcement Action: $600 Million Settlement to Protect Americans from Illegal Pharmaceuticals

FDA Special Agents, working alongside the U.S. Department of Justice, are proud to announce a landmark result in the fight against illegal online drug sales.

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.