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 »On Health Policy
NCHR Comments on The E6(R3) Guideline for Good Clinical Practice and International Council for Harmonisation Draft Guidance
September 5, 2023: We support the overall goals of the Good Clinical Practices International Council Harmonisation guidance. But we recommend strengthening diversity criteria and providing objective trial oversight while leveraging stakeholder engagement committees to improve study quality and participant safety.
Read More »NCHR Comments on the CMS Notice on Transitional Coverage for Emerging Technologies (TCET).
August 28, 2023: We support the overall goals of the TCET program, but we see an enormous disconnect between the types of evidence that FDA requires for breakthrough devices and the CED standards that CMS requires for coverage.
Read More »NCHR Comment on the CMS National Coverage Analysis Evidence Review Proposed Guidance
August 21, 2023: We support the methodological attributes of clinical studies that are described in the NCA guidance. We also strongly agree with CMS’s priorities that emphasize evidence of meaningful health outcomes, particularly morbidity and mortality, since those can be evaluated more objectively.
Read More »NCHR Comments on the CMS Coverage with Evidence Development Proposed Guidance Document
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 »