On Health Policy Archives

NCHR Comments to FDA on the Draft Guidance Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act

September 12, 2023: Noncompliance with required post-market studies (PMRs) is a serious problem that undermines FDA’s authority and the public trust in FDA decision-making.NCHR supports the process described in the guidance for applicants to correct circumstances that led to non-compliance with the agreed upon PMRs; however, we urge that the description of the actions taken by the applicant to address these issues be more explicit and less subjective.

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.

NCHR Comments on The E6(R3) Guideline for Good Clinical Practice and International Council for Harmonisation Draft Guidance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.

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.

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.