August 31, 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: IV Start Kit Issue from Avid Medical
• Early Alert: Angiographic Catheter Issue from Boston Scientific
• 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB Container by B. Braun Medical
• AVID Medical Issues Correction for Kits Containing Medline Namic Star Off Handle Manifolds
• Early Alert: Esophageal pH Monitoring Capsule Delivery Device Issue from Medtronic and Given Imaging
• Early Alert: Heart Pump Controller Issue from Abiomed
• Two Lots of 0.9% Sodium Chloride Injection by Baxter
• Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection System
• One Lot of Anticoagulant Sodium Citrate Solution by Baxter
• One Lot of 70% Dextrose Injection by Baxter
• Early Alert: Ventilator Issue from CooperSurgical
• Early Alert: Nitric Oxide Delivery System Issue from NOxBOX
• One Lot of Thyroid Tablets USP, 30 mg by Vitruvias Therapeutics

Updates

• Aug. 28, 2026 - FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder
• Aug. 28, 2026 - FDA Authorizes Marketing of JUUL2 E-Cigarette Device and Tobacco- and Menthol-Flavored Pods
• Aug. 28, 2026 - FDA Approves Stelara for Pediatric Ulcerative Colitis
• Aug. 28, 2026 - Explaining the FDA’s Classification of the Taylor Farms de Mexico Iceberg Lettuce Recall
• Aug. 28, 2026 - Mammography Problems at Mammography Center of Monterey in Monterey, California: FDA Safety Notification
• Aug. 26, 2026 - Outbreak Investigation of Listeria monocytogenes: Soft Cheese (June 2026)
• Aug. 27, 2026 - Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026)
• Aug. 27, 2026 - FDA Issues Emergency Use Authorization for Generic Drug to Prevent New World Screwworm in Cattle 
• Aug. 27, 2026 - FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults 
• Aug. 25, 2026 - FDA Approves Eugenol Sedative for Field Use in Freshwater Finfish
• Aug. 25, 2026 - FDA Approves Drug to Treat HIV Infection in Newborns
• Aug. 25, 2026 - FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar
• Aug. 25, 2026 - FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia
• Aug. 25, 2026 - FDA READI-Home Innovation Challenge: Reducing Readmissions through Device Innovation for the Home
• Aug. 25, 2026 - FDA Approves Zanidatamab-hrii and Tislelizumab-jsgr for HER2-positive Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Spotlight

FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer

The FDA approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanced pancreatic cancer months ahead of schedule.  This action demonstrates the agency’s commitment to moving with urgency, reducing unnecessary delays and advancing innovative treatments that can make a meaningful difference in the lives of American patients and their families.

Guidance Documents

• Draft CVM GFI #256B - Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities
• CVM GFI #150 Concerns Related to the use of Clove Oil as an Anesthetic for Fish

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

FDA/Duke-Margolis Institute for Health Policy Virtual Public Meeting: Innovation in Quantitative Medicine Summit

Date: Tuesday, Sept. 1, 2026; noon - 4 p.m. ET

The Duke-Margolis Institute for Health Policy and the FDA Quantitative Medicine Center of Excellence (QM CoE) will co-convene a virtual workshop to inform the establishment of the Quantitative Medicine Innovation Network (QMIN).  The QMIN will bring together stakeholders for a cross-sector collaboration of quantitative medicine (QM) to fundamentally transform drug development and clinical care.  The sessions will identify priority scientific and regulatory gaps that a coordinated network is uniquely positioned to address, examine lessons learned from established collaborative models in and adjacent to the drug development space, and discuss the governance structures, incentive frameworks, and resource-sharing mechanisms needed to sustain meaningful participation.

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

Date: Monday, 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.

Considerations for Potential Future Therapeutic Use of Psychedelic Drugs Public Hearing

Date: Monday, Sept. 14, 2026; 12:30 - 4:30 pm ET

The FDA is announcing a public hearing, held in collaboration with federal partners, to obtain feedback and perspectives on issues associated with the potential future therapeutic use of drug products containing a psychedelic drug substance in supervised and supportive settings.

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

ICYMI!

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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.