FDA Publishes Informed Consent Final Guidance for Drug and Medical Device Clinical Investigations

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 The 61-page document supersedes the Agency’s “A Guide to Informed Consent” (Sept. 1998) and finalizes the draft guidance, “Informed Consent Information Sheet” (July 2014)….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