FDA Issues Health Care Stakeholders Update
The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders. You can read the FDA regulatory update for stakeholders below.
July 14, 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
Updates
- July 14, 2025 - FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3
- July 10, 2025 - Outbreak Investigation of Salmonella: Eggs (June 2025)
- July 10, 2025 - Medical Devices that Incorporate Sensor-Based Digital Health Technology
- July 10, 2025 - Artificial Intelligence-Enabled Medical Devices
- July 10, 2025 - Augmented Reality and Virtual Reality in Medical Devices
- July 10, 2025 - FDA Approves First Long-Acting Flea and Tick Treatment for Dogs
- July 10, 2025 - A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common Sense
- July 10, 2025 - FDA Embraces Radical Transparency by Publishing Complete Response Letters
- July 9, 2025 - FDA Encourages Industry Leaders to Streamline, Enhance Product Recall Communications to Safeguard Foods for Infants and Children
- July 8, 2025 - FDA Direct - Ask A Question
- July 8, 2025 - Bayesian Statistical Analysis (BSA) Demonstration Project
- July 8, 2025 - FDA Removes REMS Requirements for Embryofetal Toxicity Risk from All Endothelin Receptor Antagonist Medicines
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:
- Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility
- Infant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter Disconnection During Ventilation
- FDA Advises Consumers Not to Inhale Nitrous Oxide Products Due to Potential for Severe Adverse Events if Used for Recreational/Non-Food Purposes
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.
FDA Direct
| New! FDA Direct, Episode 11 – 100 Days of Science, Common Sense and Radical Transparency. It’s been 100 days since the new FDA Commissioner took the helm — now it’s time to answer your questions and share what’s been going on behind the scenes. In this episode, we break down how science, common sense, and transparency are shaping the FDA’s work every day. |
ICYMI!
Voluntary Qualified Importer Program (VQIP)
| The Voluntary Qualified Importer Program (VQIP) expedites review and import entry of human and animal foods into the United States. Participating importers can avoid unexpected delays at the point of import entry by importing their products more quickly. |
Webinars and Virtual Workshops
Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA)
Date: Mon, July 14, 2025; 9 a.m. - 2 p.m. ET
The FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for FYs 2028 through 2032.
CVM Public Meeting: Second Annual Animal Drug User Fee Educational Conference
Date: Tue, July 15, 2025; 9 a.m. - 5 p.m. ET
FDA’s Center for Veterinary Medicine (CVM) will host the second meeting in a series of five public meetings to provide educational sessions for stakeholders who are interested in the new animal drug approval process.
Meeting of the Oncologic Drugs Advisory Committee
Date: Thu, July 17, 2025; 8 a.m. - 12:45 p.m. ET
The Committee will discuss BLA 761440, belantamab mafodotin submitted by GlaxoSmithKline LLC, for the treatment of adults with multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior line of therapy; and in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide.
FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women
Date: Thu, July 17, 2025; 1 - 3 p.m. ET
FDA Expert Panels are roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and may offer recommendations for regulatory action. This initiative is part of the FDA’s broader efforts to apply rigorous, evidence-based standards to ingredient safety and modernize regulatory oversight, thoroughly considering evolving science and consumer health. Registration is only required for in-person listen-in attendance. This FDA Expert Panel will be live streamed over the FDA’s YouTube channel to virtually attend.
Reagan-Udall Foundation for the FDA's Annual Public Meeting of its Board of Directors
Date: Thu, July 17, 2025; 9 - 10:30 a.m. ET
FDA Commissioner Martin Makary, joined by Deputy Commissioners Grace Graham and Lowell Zeta, will sit down with Foundation CEO Susan Winckler to discuss the Administration's vision for the FDA and the priorities for the year ahead.
Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement
Date: Fri, July 18, 2025; 9 a.m. - 4 p.m. ET
The Committee will discuss supplemental New Drug Application (sNDA) 205422/S-012, for REXULTI (brexpiprazole) tablets, submitted by Otsuka Pharmaceutical Company, Ltd., for the proposed indication of treatment of adults with post-traumatic stress disorder (PTSD), in combination with sertraline.
FDA Expert Panel on Selective Serotonin Reuptake Inhibitors (SSRIs) and Pregnancy
Date: Mon, July 21, 2025; 10 a.m. - noon ET
FDA Expert Panels are roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and may offer recommendations for regulatory action. This initiative is part of the FDA’s broader efforts to apply rigorous, evidence-based standards to ingredient safety and modernize regulatory oversight, thoroughly considering evolving science and consumer health. Registration is only required for in-person listen-in attendance. This FDA Expert Panel will be live streamed over the FDA’s YouTube channel to virtually attend.
Date: Wed, July 23, 2025; 9:30 a.m. - 4 p.m. ET
The Reagan-Udall Foundation for the FDA, in cooperation with the FDA, will convene a hybrid public meeting to gather input on the clinical use and safety concerns associated with orally ingestible unapproved prescription drug products containing fluoride for use in children.
FDA Grand Rounds – Forensic Proteomics Applied to FDA-Regulated Products
Date: Thu, July 31, 2025; noon - 1 p.m. ET
Proteins and peptides are being increasingly used in therapeutic formulations. This presentation will discuss the techniques utilized at the National Forensic Chemistry Center to analyze proteins and peptides in FDA-regulated products.
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).
Compounding Quality Center of Excellence | Annual Conference
Day 1: 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.
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 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.
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.
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