FDA Releases Informed Consent Guidance for Trials

The Food and Drug Administration (FDA) has completed its long-awaited final guidance document on informed consent in clinical investigations. The document finalizes provisions set forth in a draft guidance the agency published almost a decade ago, in July 2014 (79 Fed. Reg. 41291), and it supersedes its September 1998 guidance on the topic. The guidance, announced in the Aug. 16 Fe... Read More