27 July 2014

Draft FDA Guidance for Informed Consent

The U.S. Food and Drug Administration (FDA) published a new draft guidance for informed consent this July 2014.  The guidance is intended to provide information to clinical investigators, study sponsors and institutional review boards (IRBs) about the FDA's informed consent regulations.  When finalised, this guidance will supersede FDA's previous publication, "A Guide to Informed Consent" that was issued in September 1988.  

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