FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DEMONSTRATING SUBSTANTIAL EVIDENCE OF EFFECTIVENESS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS; REVISED DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, June 24 -- Food and Drug Administration has issued a notice called: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on June 24 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry titled "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products." FDA has revised and is reissuing this draft guidance in response to public comments and to changes in drug development by focusing on gen...