August 3, 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:

• Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine Ampules
• One Lot of Papaverine Hydrochloride Injection, USP 60 mg/2 mL by American Regent
• Cefazolin in Dextrose Injection USP, 2 g/100mL (20 mg /mL) Single-Dose Infusion Bag in 100 mL By Baxter

Updates

• July 31, 2026 - FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan with Androgen Receptor Pathway Inhibitor Therapy for Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
• July 30, 2026 - Outbreak Investigation of E. coli O145:H28: Frozen Blueberries (July 2026)
• July 29, 2026 - FDA Reopens Public Comment Period for Request for Information on Butylated Hydroxytoluene
• July 29, 2026 - FDA Announces FY 2027 Animal Drug User Fee Rates for ADUFA and AGDUFA
• July 29, 2026 - FDA Announces FY2027 FSMA User Fees for VQIP and TPP
• July 28, 2026 - FDA Approves Blood Test that Screens for Colorectal Cancer
• July 28, 2026 - FDA is Seeking Data on the pH Cycling Test Model, a Non-Animal Test Method, for Testing Fluoride Toothpaste 
• July 28, 2026 - FDA Publishes Revised Draft Product-Specific Guidances for Certain Generic Peptide Products
• July 27, 2026 - Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
• July 27, 2026 - Oncology Center of Excellence Guidance Documents

Spotlight

FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.

The FDA licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed for use in the United States.  Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available.

Guidance Documents

• Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs
• Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
• Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts
• Cancer Clinical Trial Eligibility Criteria: Laboratory Values
• Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications
• Cancer Clinical Trial Eligibility Criteria: Performance Status

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

Register for the FDA’s Public Meeting on the Reauthorization of the Medical Device User Fee Amendments

Date: Wednesday, August 5, 2026; 10 a.m. - 3 p.m. ET

The FDA is announcing a hybrid public meeting entitled “Medical Device User Fee Amendments.”  The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2028 through 2032.  MDUFA authorizes the FDA to collect fees and use them for the process for the review of device applications.

Drug Repurposing: Considerations for Selection Criteria and Prioritization

Date: Wednesday, August 5, 2026; 10:30 a.m. - 5 p.m. ET

Drug repurposing refers to the identification of potential new uses – such as a new indication or a new population – of FDA-approved drugs, for which the new uses would be supported by safety and effectiveness data.  By leveraging established safety profiles, manufacturing capacity, and clinical experience, drug repurposing has the potential to accelerate patient access to effective therapies.  On August 5, 2026, the Reagan-Udall Foundation for the FDA, will convene a hybrid public meeting to discuss opportunities to expand treatment options for patients by identifying new uses for FDA-approved drugs.  The meeting will include an overview of the comments submitted in response to the recent Request for Information and discussion of potential approaches for selecting and prioritizing promising candidates for drug repurposing for unmet medical needs.

Expedited IND Pilot Program Educational Webinar for Stakeholders

Date: Thursday, August 6, 2026; 9 - 10 a.m. ET

The FDA is announcing an educational webinar on a proposal to establish the Expedited Investigational New Drug (IND) pilot program, a new program meant to accelerate the time from drug identification to first-in-human (FIH) clinical trial.  The potential pilot program which would establish a network of qualified research institutions, such as academic medical centers (AMCs), healthcare networks (HNs), contract research organizations (CROs), regulatory advisors, and/or other research or third-party review organizations (collectively called Qualified Research Institutions, or “QRIs”), who would partner with sponsors to develop and review protocols for FIH clinical trials intended for a IND submission to FDA.  FDA is holding this webinar to clarify the intent behind the program, the purpose of the RFI, and answer specific stakeholder questions that might influence your feedback on the RFI.

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.