FDA drafts guidance on demonstrating substantial evidence of effectiveness
The FDA on Thursday issued draft guidance on demonstrating “substantial evidence” of effectiveness for drugs and biologics, expanding on decades-old guidance issued to address statutory changes brought on by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Specifically, the 18-page draft guidance builds on the FDA’s 1998 guidance Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products, which detailed the FDA’s expectations for evidence to support the approval of new drugs and biologics or applications for supplemental indications in light of FDAMA’s clarification that a single adequate and well-controlled clinical trial and confirmatory evidence can be used to support approval.
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