August 21, 2023: We support the refinements to the proposed new criteria regarding the need for proper control groups and blinding in CED studies. However, we have minor suggestions that would strengthen these changes.
Read More »On Health Policy
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.
Read More »NCHR Comments on FDA Notice of Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
August 9, 2023: NCHR supports FDA’s proposed online form for allegations of potential regulatory misconduct pertaining to medical devices. We recommended revisions to preserve anonymity and make the form easier to complete.
Read More »Patient, Consumer, and Public Health Coalition Letter to CMS and HHS Regarding the CMS Requirements for Alzheimer’s Treatment Registries
August 2, 2023: The coalition urged CMS that all data collected by any of the registries are made publicly available for research purposes, and available to the public.
Read More »NCHR Comments on FDA Guidance Regarding Decentralized Clinical Trials for Drugs, Biological Products, and Devices
August 1, 2023: We asked FDA and those conducting DCTs to recognize how they could inadvertently reduce the enrollment of diverse populations when relying on digital health technologies (DHTs). NCHR then provided strategies and considerations to FDA for implementing decentralized clinical trials, including those that use DHTs.
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