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Harmonizing the Common Rule and U.S. Food and Drug Administration Human Subjects Research Regulations

On September 28, 2022, the U.S. Food and Drug Administration issued two Notices of Proposed Rule Making to harmonize FDA’s regulations pertaining to human subjects research and the review of cooperative research by a single institutional review board with those of the Federal Policy for the Protection of Human Subjects. Earlier in September, FDA also issued a draft guidance entitled “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”

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CMS Aims to Clarify Medicare Policy on Clinical Trial Coverage


Time to Read: 1 minutes Practices: Health Care

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The Centers for Medicare & Medicaid Services has recently launched a number of initiatives addressing Medicare coverage of clinical trial services, including an upcoming "Question & Answer" document on coverage of clinical trial services; proposed revisions to the national coverage decision on clinical trial services; and a revised guidance document for certain national coverage decisions. To learn more about these significant CMS initiatives, click "Download PDF."

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