September 7, 2023: We testified that FDA’s plan to reclassify hepatitis B (HBV) assays from high risk (Class III) to moderate risk (Class II) would mean lack of evidence of accuracy. Why do that when there are already accurate assays available? Lowering the standards would harm patients by resulting in inappropriate treatments.
Read More »On Medical Treatments & Products
NCHR Comments on the FDA Proposed Guidance Regarding the Registration and Listing of Cosmetic Product Facilities and Products
September 7, 2023: NCHR provided comments on the FDA guidance regarding the registration and listing of cosmetic product facilities and products required in the Modernization of Cosmetics Regulation Act of 2022. We support these requirements and provide recommendations to improve the guidance.
Read More »NCHR Comments on the Food and Drug Administration In-Home Disposal Systems for Opioid Analgesics
August 28, 2023 The FDA is assessing whether in-home disposal products can reduce opioid nonmedical use and overdose. We recommend user-friendly, accessible in-home disposal systems that rely on deactivation rather than incineration.
Read More »Testimony at the FDA Advisory Committee Meeting on the Recor Paradise Ultrasound Renal Denervation System
August 22 2023, we testified at the FDA Advisory Meeting on the Paradise Ultrasound Renal Denervation (uRDN) System used to treat hypertension, we attested that the hypertensive efficacy of the Paradise uRDN system is insufficient to justify its use as an adjunct therapy for hypertension.
Read More »NCHR Comments on the CMS proposal to Remove the National Coverage Determination (NCD) for Beta-amyloid Positron Tomography (PET Aß) in Dementia and Neurodegenerative Disease
August 16, 2023: NCHR supported expanded coverage for PET Aß under very limited circumstances, to determine if a patient is eligible for Medicare coverage of an amyloid targeting drug that has FDA approval.
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