Substantial evidence of effectiveness draft guidance revised
FDA issued a revised draft guidance clarifying the substantial evidence of effectiveness standard for drug and biologic approvals.
What this means
The FDA updated its draft guidance on how drugmakers can prove their treatments work, focusing on modern scientific methods and high-quality data to show effectiveness. The revised document clarifies that strong evidence from one well-run clinical trial plus supporting data may be enough for approval, replacing older 1998 standards. This could speed up development of new drugs by allowing more flexible approaches while maintaining rigorous safety checks.
From the source
Docket Number: FDA-2019-D-4964
Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Oncology Center of Excellence
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry titled “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.” FDA has revised and is reissuing this draft guidance in response to public comments and to changes in drug development by focusing on generating rigorous scientific evidence in the most efficient manner.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 the increasing availability of high-quality data have transformed the evidentiary landscape for drug development. Given these advances, the draft guidance discusses the many factors that can impact the strength of evidence of effectiveness for a drug and clarifies how sponsors can rely on one adequate and well-controlled clinical investigation with confirmatory evidence to satisfy the substantial evidence of effectiveness standard. When final, this guidance will replace the 1998 guidance titled “Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.
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All written comments should be identified with this document's docket number: FDA-2019-D-4964.
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Contact Point
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Reproduced from FDA Drugs (Whats New) · view original · public domain or open-licensed government work