August 4, 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

• July 31, 2025 - FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks
• July 30, 2025 - FDA Releases New Tool for Toxicity Screening of Chemicals in Food
• July 30, 2025 - Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program
• July 30, 2025 - FDA Seeks Nominations for the Tobacco Products Scientific Advisory Committee - Summer 2025
• July 30, 2025 - FDA Announces FY2026 User Fees for VQIP and TPP
• July 29, 2025 - FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
• July 29, 2025 - FDA Advisory: Do Not Feed Certain Lots of Darwin’s Natural Pet Products Pet Food Due to E. coli O157:H7 and Salmonella
• July 29, 2025 - FDA Approves Medication to Treat 2 Rare Diseases that Can Lead to Kidney Failure
• July 29, 2025 - FDA’s Office of Pharmaceutical Quality Releases a White Paper on the Economics of Quality Management Incentives
• July 29, 2025 - FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers
• July 28, 2025 - FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients
• July 28, 2025 - CEO Forums: An FDA Listening Tour to Engage Pharmaceutical and Biotech CEOs

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:

• Continuous Ventilator Correction: Philips Respironics Updates Use Instructions for BiPAP A30, A40, and V30 Devices Due to Interruptions and/or Loss of Therapy

Consumer Updates

Products Containing 7-OH Can Cause Serious Harm

The FDA recommends that consumers avoid 7-OH products, including conventional foods, dietary supplements, and those claiming to treat an ailment or disorder.  While 7-OH occurs naturally in trace amounts in the plant kratom, the FDA’s warning is for products containing 7-OH as an added ingredient or at enhanced levels, which can be dangerous.  7-OH is not approved by the FDA for any medical use and is not lawful as a dietary supplement or when added to conventional foods because it has not met the appropriate safety standard.

Guidance Documents

• Medical Device User Fee Small Business Qualification and Determination
• CVM GFI #294 - Animal Food Ingredient Consultation (AFIC)
• Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers

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.

FDA Direct

Sounding the Alarm on 7-OH

FDA Voices

FDA Advances Drug Development Innovation by Establishing ISTAND as Permanent Qualification Program

The FDA recognizes that innovating drug development is an important way to bring new treatments to patients and consumers expeditiously.  For this reason, the FDA is excited to announce that our Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program has transitioned to a permanent drug development tool (DDT) Qualification Program.  ISTAND will continue to support innovative, science-driven approaches that improve drug development and regulatory decision-making, ultimately helping to make therapies available to address patients’ unmet needs.

ICYMI!

FDA Clinical Trials Training Modules

The content reflects current FDA thinking, emerging guidance, and real-world regulatory experience, providing participants with the most reliable and up-to-date information available.  Organizations utilizing this training demonstrate their commitment to regulatory excellence and position their teams for successful interactions with health authorities worldwide.

Webinars and Virtual Workshops

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

Date: Mon, Aug. 4, 2025; 10 a.m. - 3 p.m. ET

The FDA is announcing a public meeting on the reauthorization of the Medical Device User Fee Amendments for fiscal years 2028 through 2032 (MDUFA VI).

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

Date: Wed, Aug. 13, 2025; 9 a.m. - 3:30 p.m. ET

On August 13, 2025, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Committee) will discuss a new indication for use for dermal filler devices in the décolletage area and will make recommendations regarding risks associated with new indications for use such as in the décolletage area, the potential impact of filler material on imaging studies and clinical exams (e.g., breast cancer screening), pre-market and post-market study assessments for benefit and risk, removal of dermal filler implant material, and patient preference.

Compounding Quality Center of Excellence | Annual Conference

Day1: Mon, Aug. 25, 2025; 2 - 5 p.m. ET
Day 2: Wed, Aug. 27, 2025; 9 a.m. - 6 p.m. ET
Day 3: Thu, Aug. 28, 2025; 9 a.m. - 4:30 p.m. ET

FDA’s Compounding Quality Center of Excellence will host its sixth Annual Conference.  Participants can attend this free, hybrid conference in person at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland, or virtually.  The conference will convene outsourcing facilities, pharmacy compounders and others from across the industry to discuss emerging trends and best practices through presentations, panels and interactive sessions.

Collaborating on Food Safety Culture

Date: Webinar Series 2 from Wed, Sept. 3, 2025 - Wed, Sept. 16, 2026; noon ET

The FDA and the Alliance to Stop Foodborne Illness, a non-profit public health organization, are collaborating on a webinar series that explores food safety culture.  The series, entitled Collaborating on Food Safety Culture, began on November 4, 2021.  The webinar series engages experts from the public and private sectors in a collaborative exchange of ideas and experiences related to the importance of a robust food safety culture in helping to ensure safe food production.  The series will have valuable information for both those well-versed on, and those just learning about, food safety culture.

Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act

Date: Mon, Sept. 15, 2025; 9 a.m. - 4:30 p.m. ET

The purpose of the public meeting is to seek input from interested parties including, patient/parent/caregiver groups, consumer groups, regulated industry, academia, and others.  This input will enable FDA to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, including pediatric drug and biologic development and labeling, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA).

FDA Public Meeting: BsUFA III Regulatory Science Program Interim Public Meeting

Date: Thu, Sept. 18, 2025; 9 a.m. - 3 p.m. ET

The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual meeting on September 18, 2025, to meet the BsUFA III Commitment to review the progress of the pilot program’s aims, or demonstration projects, and solicit input on future priorities.  The meeting agenda includes an overview of the regulatory science program, presentations by internal and external awardees conducting research projects under the BsUFA III regulatory science program, and panel discussions by FDA staff and representatives from the biosimilar industry.

FDA CBER OTP Public Listening Meeting: Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies

Date: Thu, Sept. 18, 2025; 10 a.m. - 4 p.m. ET

The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public listening meeting to solicit perspectives from cell and gene therapy (CGT) manufacturers and other stakeholders on leveraging prior knowledge and experience to facilitate product development and application review.

FDA Public Workshop: Future Needs for the Development of Interchangeable Products

Date: Fri, Sept. 19, 2025; 9 a.m. - 1 p.m. ET

The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual public workshop on September 19, 2025, to meet the BsUFA III commitment.  The meeting agenda includes presentations by representatives from the biosimilar industry on the future needs for the development of interchangeable products, discussions on specific interchangeable topics, and a panel discussion with industry.

Tobacco Products Scientific Advisory Committee Meeting

Date: Tue, Oct. 7, 2025; 9 a.m. - 4:30 p.m. ET

The Center for Tobacco Products’ TPSAC will meet for an open session to discuss the renewal of modified risk granted orders issued to Philip Morris Products S.A. for the following products:

• Marlboro Amber HeatSticks
• Marlboro Green Menthol HeatSticks
• Marlboro Blue Menthol HeatSticks
• IQOS 2.4 System Holder and Charger
• IQOS 3.0 System Holder and Charger

Discussion will focus on whether the statutory standards continue to be met.

FDA/The Osteosarcoma Institute (OSI) Workshop: Advancing Osteosarcoma Drug Development – Connecting Research and Regulatory Pathways for Improved Outcomes

Date: Fri, Oct. 10, 2025; 9:30 a.m. - 5 p.m. ET

The FDA Oncology Center of Excellence (OCE) and The Osteosarcoma Institute (OSI) have a shared interest in engaging with the osteosarcoma community to identify the major barriers to drug development for osteosarcoma and to discuss opportunities for collaboration to address these challenges.

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.