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.
Read More »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
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.
Read More »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.
Read More »NCHR Letter to Sen. Sanders in Support of the Childhood Diabetes Reduction Act
July 21, 2026: NCHR letter from Diana Zuckerman to Senator Bernie Sanders endorses the Childhood Diabetes Reduction Act and explains how limiting junk food ads to kids, requiring front-of-package warning labels on ultra-processed food and other unhealthy food, and supporting NIH research on ultra-processed foods could improve children’s health.
Read More »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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