The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The 61-page document supersedes the Agency’s “A Guide to Informed Consent” (Sept. 1998) and finalizes the draft guidance, “Informed Consent Information Sheet” (July 2014)….
By: Nelson Mullins Riley & Scarborough LLP
By: Nelson Mullins Riley & Scarborough LLP