Federal Register #FDA-2019-D-4964

FDA Releases Revised Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products

This opportunity involves the release of a revised draft guidance by the Food and Drug Administration (FDA) regarding the demonstration of substantial evidence of effectiveness for human drug and biological products. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - No OEMs or vendors are mentioned in this notice - No products or services are being procured or requested - Key Details: - The guidance aims to help industry generate rigorous scientific evidence efficiently - Reflects advances in biological understanding and data availability - Clarifies evidentiary standards for drug effectiveness, including reliance on one adequate and well-controlled clinical investigation with confirmatory evidence - Will replace the 1998 guidance on clinical evidence of effectiveness for human drug and biological products - Notice is for public comment on the draft guidance, not a procurement action

Description

The Food and Drug Administration (FDA) has announced the availability of a revised draft guidance for industry titled "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products." This guidance focuses on generating rigorous scientific evidence efficiently, reflecting advances in biological understanding and data availability. It discusses factors impacting the strength of evidence for drug effectiveness and clarifies how sponsors can rely on one adequate and well-controlled clinical investigation with confirmatory evidence to meet the substantial evidence standard. When finalized, this guidance will replace the 1998 guidance on providing clinical evidence of effectiveness for human drug and biological products.

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