August 18, 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 14, 2025 - FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis
• August 13, 2025 - Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products
• August 13, 2025 - FDA Issues Warning About Imported Cookware That May Leach Lead: August 2025
• August 12, 2025 - Warning Letters
• August 11, 2025 - FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Frozen, Raw, Half-shell Oysters from Republic of Korea Potentially Contaminated with Norovirus

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:

• Early Alert: Cardiac Cannula Issue from Medtronic
• Early Alert: Infusion Pump Issue from Baxter
• FDA Approves Drug for Chronic Inflammatory Lung Condition in Patients 12 and Older
• Draeger Recalls SafeStart, TwinStar Filters

Consumer Updates

Understanding FDA Terms for Possible New Therapies to Prevent and Treat Diseases

The FDA is responsible for protecting the public health by, among other things, ensuring the safety and effectiveness of drugs, biological products and medical devices.  In certain circumstances, the FDA allows the emergency use of medical products that do not yet have agency approval.  The language used to describe potential treatments can be confusing.  Here’s what some of those terms mean.

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!

Rare Disease Endpoint Advancement Pilot Program

FDA is accepting proposals on a quarterly basis for the Rare Disease Endpoint Advancement (RDEA) Pilot Program!  Our Center for Biologics Evaluation and Research welcomes your submission to this joint pilot program with our Center for Drug Evaluation and Research.

Webinars and Virtual Workshops

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.

Eco-NAMs Webinar Series | State of the Science for Bioaccumulation: An Integrated, Weight of Evidence Approach

Date: Wed, Sept. 10, 2025; 8-9 a.m. ET

The Eco-NAMS webinar series is co-organized by the FDA, U.S. Environmental Protection Agency, European Medicines Agency, Health and Environmental Sciences Institute, National Institute for Environmental Studies (Japan), and PETA Science Consortium International e.V.  The series aims to offer the most informative and up-to-date science on the use of new approach methodologies (NAMs) for ecotoxicity assessments (Eco-NAMs) and provides an open forum for scientists from academia, industry, non-government organizations, regulatory authorities, and other interested parties including the general public to learn about and discuss various ecotoxicity NAMs topics.

Lessons Learned from the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program

Date: Wed, Sept. 10, 2025; 1-5 p.m. ET

FDA and the Duke-Margolis Institute for Health Policy will host a virtual workshop on September 10, 2025, that will delve into the challenges and strategies for expedited chemistry, manufacturing, and controls (CMC) development.  The meeting will feature perspectives from both industry leaders and FDA regulators, who will discuss best practices and lessons learned from the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program.

FDA-AACR Workshop: Approach to Novel Oncology Endpoint Development - Virtual

Date: Thu, Sept. 11, 2025; 9 a.m. ET

Join virtually the FDA-AACR Workshop: Approach to Novel Oncology Endpoint Development, a one-day meeting that will bring together experts from regulatory agencies, academia, industry, and advocacy to discuss the development and application of novel endpoints in oncology drug development.  This collaborative forum will explore scientific and regulatory considerations, emerging data, and future directions for endpoint innovation in cancer research and treatment.

ICH M13B Webinar: Navigating the Draft ICH M13B Additional Strengths Biowaiver Guideline

Date: Thu, Sept. 11, 2025; noon - 2 p.m. ET

This webinar will provide an in-depth look at the draft ICH M13B guideline titled "Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver" that was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly in March 2025.

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/Center for Research on Complex Generics (CRCG) Workshop on Mastering Particle Size Analysis: A Step-By-Step Illustration of Techniques and Best Practices

Day 1: Tue, Sept. 23, 2025; 9:30 a.m. - 4 p.m. ET
Day 2: Wed, Sept. 24, 2025; 8:30 a.m. - 4:20 p.m. ET

This 2-day hybrid workshop addresses challenges in particle size characterization for complex generic drug products.  It aims to enhance understanding of Dynamic Light Scattering (DLS) and Laser Diffraction (LD) techniques, tackle method development and validation issues, and provide hands-on experience with equipment.  By bringing together industry experts, regulatory scientists, and instrument vendors, the workshop fosters collaboration to overcome hurdles in generic drug development, identify research needs, and improve regulatory guidance.  Participants will gain valuable insights through theoretical presentations, practical demonstrations, and interactive discussions.

Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned

Date: Tue, Sept. 23, 2025; 9:30 a.m. - 4 p.m. ET

During this meeting, experts will discuss lessons learned from case studies in which RWE was used for regulatory decision-making for medical products.  Speakers will highlight FDA’s efforts with RWD/E to date and approaches to generate RWE to meet regulatory requirements.  This convening fulfills both a PDUFA VII and a MDUFA V requirement.

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.

Pediatric Developmental Safety Assessment: New Approach Methods

Date: Fri, Dec. 5, 2025 - 8 a.m. - 4 p.m. ET

The FDA in collaboration with the Triangle Center of Excellence in Regulatory Science and Innovation (Triangle CERSI) will host a public workshop entitled “Hybrid Public Workshop: Pediatric Developmental Safety Assessment and New Approach Methodologies” on December 5, 2025.  The goal of this workshop is to discuss new approach methods that can address pediatric developmental safety during drug development.

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.