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.
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NCHR Comments on the FDA’s Use of Generally Accepted Medical Knowledge Draft Guidance
July 24, 2023: The FDA proposed a draft guidance on using generally accepted medical knowledge (GASK) when conducting nonclinical studies to help streamline product development, decrease costs, and hasten new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Read More »NCHR Comments on FDA’s Bioequivalency for Generic Drug Formulations Draft Guidance
July 18, 2023: FDA draft guidance on bioequivalency is intended to streamline generic drug development and speed up patients’ access to generic medications. But some shortcuts that FDA proposes could result in unsafe generic medications that were not adequately tested. We highlight research standards that will help keep patients safe.
Read More »NCHR Comments on USPSTF Draft Recommendation on Breast Cancer Screening
June 6, 2023: The U.S. Preventive Services Task force has changed its recommendations for mammography to start at age 40 instead of 50. However, they still recommend mammograms every 2 years instead of every year. We point out that there are racial differences in cancer risk and that mammography guidelines should reflect those racial differences. One size does not fit all.
Read More »NCHR Comments on the FDA Draft Guidance on Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics
May 26, 2023: FDA draft guidance contained numerous recommendations that would improve the quality of research submitted in support of accelerated approval for oncology drugs. However, we recommended the FDA explicitly specify that studies need to have a majority of patients enrolled prior to receiving accelerated approval and that they advise against the use of single-armed trials.
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