July 27, 2023: In a letter to CMS and HHS, policy experts and bioethicists urge CMS to require that registries that make Medicare patients eligible for Leqembi coverage share data with CMS, FDA, and independent researchers to ensure accurate and unbiased data.
Read More »Author: Caroline Bradford
Testimony of Dr. Diana Zuckerman On Bill H.3948
July 26, 2023: We provided written testimony in support of Massachusetts bill H 3948, which would prohibit state and municipal contracts to install artificial turf fields. In October, the bill was reported favorably.
Read More »NCHR Comments on the FDA’s Use of Generally Accepted Medical Knowledge Draft Guidance
July 24, 2023: The FDA proposed a draft guidance on using generally accepted medical knowledge (GASK) when conducting nonclinical studies to help streamline product development, decrease costs, and hasten new product approval time. We do not recommend using GASK as the sole source of nonclinical data in new drug applications or biologic license applications as this could jeopardize the safety, toxicology, and efficacy of the product.
Read More »NCHR Comments on the FDA Notice Regarding Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies (REMS)
July 19, 2023: NCHR urged FDA to require drug sponsors and their REMS administrators to test proposed changes to REMS systems prior to implementation. FDA should also require stakeholder input from prescribers in all stages of developing, implementing, and tracking a REMS modification.
Read More »Patient, Consumer, and Public Health Coalition Letter to FDA Commissioner Califf Regarding FDA Advisory Committee Meetings
July 7, 2023: The Coalition expressed our strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
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