NCHR Written Comment on HHS National Plan To Address Alzheimer’s Disease

August 14, 2026: In response to a request for public comments, NCHR urged HHS to strengthen the ‘National Plan to Address Alzheimer’s Disease’ by improving research that directly informs patient care, treatment decisions, and quality of life for people living with AD/ADRD. We recommend requiring NIH to immediately analyze CMS registry data on Leqembi and Kisunla, and require the other anti-amyloid registries to make data available to HHS for NIA and NINDS to analyze the data and make it public. NCHR also called for stronger oversight of potentially deadly antipsychotic medications used for dementia patients and greater support for patients, families, and caregivers.

Read More »

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.

Read More »

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 »