- Posts by Rachel Weisblatt
Member of the FirmAttorney Rachel Weisblatt helps health care clients ensure compliance with federal and state regulations and guides them through a wide variety of transactional matters. She works with clients throughout the health care and life ...
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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. The Final Guidance is intended to assist clinical research stakeholders, such as institutional review boards (“IRBs”), investigators, and sponsors, in complying with FDA’s informed consent regulations for clinical ...
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