August 11, 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

• August 8, 2025 - FDA Commissioner Makary, USDA Secretary Rollins Celebrate Proposed Modernization of Orange Juice Regulations to Benefit American Growers
• August 8, 2025 - FDA Grants Accelerated Approval to Zongertinib for Non-Squamous NSCLC with HER2 TKD Activating Mutations
• August 8, 2025 - A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: Announcing Resolution of the IV Saline Solutions Shortage
• August 8, 2025 - FDA PreCheck Program to Boost U.S. Drug Manufacturing
• August 8, 2025 - Report on the State of Pharmaceutical Quality
• August 7, 2025 - FDA’s Actions to Address Unapproved Thyroid Medications
• August 7, 2025 - Upcoming FDA Oncology Events; Recent Approvals and Publications
• August 7, 2025 - FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing
• August 6, 2025 - PFAS in Medical Devices
• August 6, 2025 - FDA Grants Accelerated Approval to Dordaviprone for Diffuse Midline Glioma
• August 6, 2025 - FDA Proposes to Extend Compliance Date for Food Traceability Rule and Issues New FAQs and Other Resources
• August 5, 2025 - Investigations of Foodborne Illness Outbreaks
• August 5, 2025 - FDA Issues Proposed Rule to Amend Standard of Identity for Pasteurized Orange Juice
• August 4, 2025 - FDA Names Top HHS Lawyer as Chief Counsel

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:

• DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products by DermaRite Industries
• FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live)
• Early Alert: WATCHMAN Access System Issue from Boston Scientific
• Early Alert: Medline ReNewal Electrophysiology Catheter Issue
• Per- and Polyfluoroalkyl Substances (PFAS) in Medical Devices
• Early Alert: Defibrillation Lead Issue from Boston Scientific

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.

ICYMI!

Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)

As part of the Accelerating Rare disease Cures (ARC) Program, FDA Center for Drug Evaluation and Research (CDER) Rare Diseases Team (RDT) inaugurated the Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) initiative to better understand and address the unique challenges in bringing rare disease products regulated by FDA CDER to the market.  Rare disease drug development can be challenging for numerous reasons, such as small -and sometimes very small- patient populations, genotypic/phenotypic heterogeneity within a disease, and novel endpoint development and selection, all in the context of often serious and life-threatening diseases without approved therapies.  The goal of LEADER 3D is to develop educational content based on the needs of rare disease drug development stakeholders.

Webinars and Virtual Workshops

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.

The Future of Registries in Oncology

Day 1: Wed, Aug. 27, 2025; 10 a.m. - 1 p.m. ET
Day 2: Thu, Aug. 28, 2025; 10 a.m. - 1 p.m. ET

The FDA Oncology Center of Excellence is hosting a pivotal two-day virtual workshop on August 27-28, 2025: The Future of Registries in Oncology.  Day 1- Best Practices for Innovation in Drug Development - will cover foundational concepts and best practices for oncology registry development, showcasing successful examples that have supported regulatory decision-making.  Day 2 - Advancing Drug Development in Pediatric Diffuse Midline Glioma (DMG)/ Diffuse Intrinsic Pontine Glioma (DIPG) - will dive deep into current national and international efforts to build patient registries for DMG/DIPG, facilitating forward-looking discussions on optimal design and implementation strategies.

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 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 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.

FDA Public Meeting: Onshoring Manufacturing of Drugs and Biological Products

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

In response to Executive Order (EO) 14293, FDA has developed a proposal, FDA PreCheck to accelerate the establishment of high priority new pharmaceutical manufacturing facilities in the U.S. and strengthen the domestic pharmaceutical supply chain.  Specifically, the proposal consists of a two-phase approach: (1) Facility Readiness Phase, and (2) Application Submission Phase.  In Phase 1, the Facility Readiness Phase, selected manufacturers can engage with FDA for early technical advice before a facility is operational through pre-operational reviews and utilization of a facility-specific Drug Master File to facilitate efficient evaluation of facility-specific elements prior to, and in support of, the submission of a drug application.  In Phase 2, the Application Submission Phase, FDA and applicants build upon Phase 1 and engage through pre-submission meetings to resolve issues and expedite assessments of quality information in a drug application and inspections.

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.