April 27, 2026: NCHR raises concerns about the FDA’s proposed plausible mechanism framework for therapies targeting rare and genetic diseases, warning that reliance on such very limited evidence makes it difficult or impossible to make informed choices based on safety and effectiveness, and means even more very high costing unproven drugs, which patients will pay for directly or through health insurance.
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NCHR Written Comment on why the Department of Education’s Proposal to Reduce Graduate Student Loans for Nurses and Therapists would worsen shortages in access to health care
March 2, 2026: In response to a request for written comments, NCHR warned the U.S. Department of Education warning that its proposed graduate student loan limits would worsen the shortages of nurses, clinical psychologists, physical therapists, occupational therapists, and clinical social workers. Higher loan levels are needed to reverse national workforce shortages and provide essential healthcare, especially in rural, underserved, and less populated areas of the U.S.
Read More »NCHR Written Comment on Exempting AI and Computer-Assisted Medical Devices from FDA Regulation and Safeguards
February 27, 2026: In response to a request for written comments, NCHR told the FDA why we oppose exemptions from 510(k) premarket review for computer-aided radiology devices. NCHR warns that these tools can influence diagnosis and triage decisions and should undergo rigorous evaluation to ensure safety, effectiveness, and equitable performance in real-world clinical settings.
Read More »NCHR Comment on the Reauthorization of MDUFA
September 4, 2025: NCHR’s written public comment to FDA on MDUFA says user fees should support improvements in safety and effectiveness by paying for salaries for staff to improve premarket review, post-market surveillance and other activities, and inspections of manufacturing facilities. Industry has benefitted from MDUFA’s speedier reviews and more meetings with FDA staff, but what patients and consumers need most is safer and more effective medical devices. We deserve clear information about risks and benefits, and we can’t get that when 96+% of devices are not studied in clinical trials before being sold.
Read More »NCHR Public Comment on the Continued Implementation of the National Youth Tobacco Survey
In our public comment to the CDC, we strongly supported the continued operation of the National Youth Tobacco Survey (NYTS) for the 2026-2028 cycle. NYTS is the cornerstone of public health surveillance in this field and we reminded CDC and FDA that evaluating the youth use of tobacco products is an essential tool of U.S. public health strategies to reduce cancer, heart disease, and chronic diseases that are key to the MAHA movement.
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