April 28, 2025

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

Updates

• April 23, 2025 - FDA  Approves Penpulimab-kcqx for Non-Keratinizing Nasopharyngeal Carcinoma
• April 23, 2025 - Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
• April 22, 2025 - HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply

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:

• Heart Pump Accessory Removal by Abbott: Alert - Due to Instances of Sudden Power Loss
• FDA Alerts Health Care Providers, Compounders and Consumers of Potential Risks Associated with Compounded Topical Finasteride Products
• Risk of False Positive Results with Certain Capillary Blood Collection Tubes by Magellan Diagnostics LeadCare Testing Systems
• 072 Aspiration System (Hippo) by Q’Apel Medical
• Ropivacaine Hydrochloride Injection USP, 500 mg/100 mL by Amneal Pharmaceutical
• Early Alert: Diagnostic Intravascular Catheter Issue from Conavi
• Early Alert: Intravascular PICC Catheter Issue from BD

ICYMI!

Using Cosmetics Safely

Understanding Cosmetic Labels

Guidance Documents

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

Implementing FDA’s IVPT Guidance Recommendations: A Step-By-Step Illustration - Workshop

April 29 - 30, 2025

Day 1: Tue, Apr 29; 8:30 a.m. - 5:30 p.m. ET
Day 2: Wed, Apr 30; 8:30 a.m. - 3:30 p.m. ET

The In Vitro Permeation Test (IVPT) is an important performance test used by the generic drug industry to support demonstrations of bioequivalence for generic topical drug products, when utilizing efficient characterization-based bioequivalence approaches.  The workshop will clarify the intent of FDA recommendations for IVPT studies, with step-by-step demonstrations illustrating how IVPT study procedures can be performed in a manner compatible with recommendations in FDA’s Guidance for Industry.

UPDATED MEETING DATE AND PUBLIC PARTICIPATION INFORMATION: May 5, 2025 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement

Mon, May 5, 2025; 8:00 a.m. - 5:00 p.m. ET

The Committees will discuss the findings of the completed ER/LA OA PMRs 3033-1 and 3033-2 (link to Release and Reissue letter).  These PMRs are prospective (3033-1) and retrospective (3033-2) epidemiologic studies that examined the serious risks and predictors of misuse, abuse, addiction, and fatal and non-fatal opioid overdose in patients with long-term use of opioid analgesics for management of chronic pain, including patients prescribed ER/LA OAs.

Registration is not necessary.

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.