Better Late Than Never: FDA Issues Long-Awaited Final Informed Consent Guidance

After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet guidance document (Draft Guidance) and supersedes the 1998 FDA guidance document, “A Guide to Informed Consent.” FDA issued the Final Guidance as part of an ongoing effort to modernize and harmonize its human subject protection policies and regulations....
By: