Federal Register #FDA-2023-D-5259

FDA Draft Guidance on Master Protocols for Drug and Biological Product Development

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has released a draft guidance for industry regarding master protocols in drug and biological product development. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are mentioned in this notice - No products or services are being requested - Key details of the draft guidance: - Provides recommendations for designing and analyzing clinical trials using master protocols - Focuses on randomized trials to demonstrate safety and substantial evidence of effectiveness - Applies to a broad range of therapeutic areas - Addresses trial oversight, data sharing, regulatory submissions, randomization, control groups, informed consent, blinding, adaptive design, and safety - Unique requirements: - Clarifies FDA's current thinking on the use of master protocols in clinical development - Emphasizes regulatory considerations for complex trial designs - This is an informational notice only; no procurement action is being solicited

Description

The Food and Drug Administration (FDA) has released a draft guidance for industry titled "Master Protocols for Drug and Biological Product Development." This guidance revises and replaces a previous draft issued in December 2023 and provides recommendations on the design and analysis of trials conducted under a master protocol, focusing primarily on randomized trials intended to demonstrate safety and effectiveness. It applies across a range of therapeutic areas and aims to clarify the FDA's approach to master protocols in drug and biological product development. The guidance also addresses trial oversight, data sharing, and regulatory submissions.

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