September 25, 2023: NCHR supported the use of Dietary Guidance Statements to reduce nutrition-related chronic diseases and advance health equity. We made recommendations regarding dietary statements for products that exceed recommended amounts, or contain fruit juice, whole grains, and alcohol.
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NCHR Comments on the Proposed Framework from Ranking Member Cassidy to Regulate Artificial Intelligence (AI) in Healthcare
September 22, 2023: NCHR urged the need to reform the 510k clearance pathway for AI/machine learning (ML) devices, promote diversity in the data used for AI, and the need to routinely test effectiveness of updated systems, including post market surveillance.
Read More »NCHR Comments to FDA on the Draft Guidance Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act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.
Read More »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Read More »NCHR Comments on The E6(R3) Guideline for Good Clinical Practice and International Council for Harmonisation Draft Guidance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.
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