Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry titled "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products." FDA has revised and is reissuing this draft guidance in response to public comments and to changes in drug development by focusing on generating rigorous scientific evidence in the most efficient manner. Advances in our understanding of biological processes and t