FDA

The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee will hold a public meeting on July 30, 2026 from 9:30 a.m.–4:50 p.m. ET to review the biologics license application and provide independent expert recommendations. The committee will discuss Replimune, Inc.’s Biologics License Application for vusolimogene oderparepvec, proposed for use in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD-1-containing regimen. Advisory committee meetings are open to the public and play an important role in bringing independent scientific and clinical expertise to FDA’s review process. Follow the discussions live and learn more about the meeting. https://lnkd.in/euNc9d77

In response to stakeholder requests, the FDA is reopening the public comment period for its Request for Information on butylated hydroxytoluene in human food and as a food contact substance.    The extension provides additional time for interested parties to submit comments as part of the FDA's systematic process for conducting post-market assessments of chemicals in food.    Comments may be submitted through Federal Register docket FDA-2026-N-2526 through August 31, 2026. https://lnkd.in/emAF9ZBK

Today, the FDA licensed the first freeze-dried plasma product in the United States. Ezplaz (Freeze Dried Plasma) can be stored at room temperature, is stable after temperature extremes, and is rapidly reconstituted — which will provide significant help for emergency care and military medicine. Ezplaz also introduces a global first: freeze-dried plasma packaged in a plastic bag, replacing the glass vials traditionally used for lyophilized blood products. This innovation will improve durability and portability in harsh environments where glass breakage is a critical risk. This product was developed as part of the FDA–DoD (now DoW) collaboration under Public Law 115-92. https://lnkd.in/eypDhKeX

The FDA has announced the FY 2027 fee rates and payment procedures for animal drugs subject to user fees under the Animal Drug and Animal Generic Drug User Fee Amendments of 2023. The ADUFA and AGDUFA user fee programs supplement congressional funding to support the review of animal drug and generic animal drug applications and help ensure safe and effective products for animals. Learn more: https://lnkd.in/emCs8cFu

FASTPASS has significant potential to strengthen FDA's ability to screen imported pharmaceutical products — quickly, efficiently, and at the point of entry. FDA's operational expertise, combined with ARPA-H's innovation capacity, can produce a tool that meaningfully advances public health protection at the border. https://lnkd.in/ezYXM3Rq

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The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee will hold a public meeting on July 29, 2026 from9:30 a.m.–4:50 p.m. ET to review the biologics license application and provide independent expert recommendations.    The committee will discuss Capricor, Inc.’s Biologics License Application for deramiocel (human allogeneic cardiosphere-derived cells) for the treatment of cardiomyopathy in Duchenne muscular dystrophy (DMD).   Advisory committee meetings are open to the public and play an important role in bringing independent scientific and clinical expertise to FDA’s review process. Follow the discussions live and learn more about the meeting. https://lnkd.in/efZNh2hn

Your voice matters to the FDA! Are you — or someone you care for — living with End-Stage Renal Disease (ESRD) and receiving home hemodialysis? We want to hear from you.   🗓️ FDA Patient Listening Session: ESRD & Home Hemodialysis 📅 Monday, September 28, 2026 | 1:00 – 2:30 p.m. ET   What to expect: A small group of patients and caregivers will share their firsthand experiences with FDA staff, covering topics like treatment choices, quality of life, device usability, independence, telehealth support, and education needs — all to help improve the home hemodialysis experience.   Who can apply: Patients and caregivers living with ESRD who are currently receiving home hemodialysis. Participants will be selected to represent a range of ages, locations, symptoms, and disease severity.   Space is very limited! Interested in participating? Complete our brief interest survey by August 10, 2026: 🔗 https://lnkd.in/eHtpU4J3   Help the FDA better understand what it's like to live with ESRD and receive home hemodialysis.   #ESRD #KidneyDisease #KidneyFailure #Hemodialysis #HomeHemodialysis

FDA is seeking data on the pH cycling test model, a non-animal test method, for testing fluoride toothpaste.    We've issued a data request asking for scientific data to help inform whether the pH Cycling Test Model should be included as a testing procedure for OTC fluoride toothpaste products.    The pH cycling test model is a laboratory-based, non-animal test that mimics a specific aspect of the natural process of tooth decay and the role of fluoride toothpaste in its prevention.    We're looking for data, including:  ✅ Standardized test protocol  ✅ Multi-site validation study results  ✅ A comparison to existing animal-based test results    The docket is open for 6 months. Visit the link below to read the Data Request and learn how to submit.    🔗 https://lnkd.in/e5fqEj23

Today, FDA published revised draft product-specific guidances (PSGs) for certain peptide drug products. These revised PSGs provide updated recommendations across five key areas:  • Submission of recombinant, synthetically, or semi-synthetically produced peptides as an abbreviated new drug application (ANDA)   • Innate immune response testing  • Impurity thresholds   • Higher order structure assessment   • Biologic activity assessment for certain generic peptide drug products.  The PSGs address medications that include, but are not limited to, those used to manage obesity and treat type 2 diabetes, osteoporosis, and macular degeneration. When finalized, these PSGs will reflect FDA's current thinking for developing generic drug products and generating evidence to support FDA approval of these products. Learn more: https://lnkd.in/eR_dpQYT