Public Comment of Generation Patient, National Center for Health Research, Patient Safety Action Network, and USA Patient Network in response to the Medical Device User Fees Amendments (MDUFA) VI Stakeholders Process and Commitment Letter

August 7, 2026. In response to a request for public comments by the FDA on proposed recommendations for reauthorizing the Medical Device User Fee Amendments (MDUFA) VI for fiscal years 2028–2032, the National Center for Health Research urged the FDA to improve the FDA’s Commitment letter with industry to ensure clinical trial results are available in clinicaltrials.gov prior to devices going on the market, provide resources for post-market surveillance, and reduce industry demands on deficiency letters.

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NCHR Public Comment on FDA Medical Device User Fee Amendments (MDUFA) VI for 2027-2032

August 7, 2026. In response to a request for public comments by the FDA on proposed recommendations for reauthorizing the Medical Device User Fee Amendments (MDUFA) VI for fiscal years 2028–2032, the National Center for Health Research urged the FDA to improve the FDA’s Commitment letter with industry to ensure clinical trial results are available in clinicaltrials.gov prior to devices going on the market, provide resources for post-market surveillance, and reduce industry demands on deficiency letters.

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Expedited Investigational New Drug (IND) Pilot Program- Request for Information

July 21, 2026, In response to a request for public comments, NCHR wrote to the FDA opposing the Expedited Investigational New Drug Pilot Program as proposed while offering recommendations to strengthen it if implemented. NCHR warned that sponsor-funded Qualified Research Institutions could create conflicts of interest and weaken independent oversight. NCHR emphasized that any effort to accelerate first-in-human trials must prioritize participant safety, scientific integrity, transparency, and FDA accountability over speed.

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NCHR Written Comment to FDA on the National Youth Tobacco Survey

July 6, 2026: In response to a request for public comments, NCHR wrote to the FDA strongly supporting the continuation of the National Youth Tobacco Survey for 2027-2029. NCHR emphasized that NYTS is essential for tracking youth tobacco and nicotine use, including e-cigarettes, nicotine pouches, and other emerging products, and for understanding whether new products contribute to combustible cigarette use, dual use, or sustained nicotine addiction. The survey provides critical data to guide prevention, enforcement, education, and evidence-based tobacco control policies that can be used to reduce addiction and dangerous heath habits by children and adolescents.

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