July 19, 2022. We support the proposed policy as a positive step to increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace and to promote risk-based regulation. Having data is essential; reducing manufacturers’ fear of reprisal for submitting late data creates an incentive to provide that information. However, we support greater monitoring and enforcement of premarket notifications to reduce late submissions in the future, and to reduce manufacturers’ failure to submit NDIs in a timely manner.
Read More »On Health Policy
NCHR Comments to CMS on Beta Amyloid Positron Tomography in Dementia and Neurodegenerative Disease
July 15, 2022: We agree that there is evidence that PET Aß imaging is a useful tool to support a diagnosis of Alzheimer’s Disease as part of a clinical trial protocol. However, there are conflicting data regarding its usefulness to determine the effectiveness of Alzheimer’s Disease treatment strategies.
Read More »Patient, Consumer, and Public Health Coalition Letter to Senate HELP and Energy and Commerce Committee Regarding User Fee Reauthorization Legislation
July 12, 2022: We write to urge you to expeditiously consolidate the two pieces of legislation to reauthorize the Food and Drug Administration (FDA) user fee programs for medical products. We request your consideration on reform to the accelerated approval pathway, clinical trial diversity, and new oversight of dietary supplements, cosmetics, and lab-developed diagnostic tests.
Read More »NCHR Comments on Fostering Medical Device Improvement
July 5, 2022: This proposed draft guidance on Fostering Medical Device Improvement aligns closely with the needs of medical device companies, but not with the needs of patients and consumers. NCHR has many concerns about the proposed program.
Read More »NCHR’s Public Comment on Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting
June 21, 2022: While we agree that these potential modifications are a great step forward in ensuring that unused medications are properly disposed of, overprescribing continues to be a major problem in the U.S. There should be continued efforts to educate physicians and pharmacists on reducing the number of opioids prescribed and providing alternatives to opioid analgesic prescriptions…
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