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FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more

OSTP Releases Highly Anticipated Guidance on National Security Strategy for Federally Funded Research

On January 4, 2022, the White House Office of Science and Technology Policy (OSTP) issued the long-anticipated guidance for federal agencies to implement National Security Presidential Memorandum (NSPM)-33. Encouraging an...more

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