March 10, 2023 at 05:47PM Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research

The purpose of this guidance is to describe the recommendations of the Center for Biologics Evaluation and Research (CBER) on the use of standards in product development and control as well as the use of such standards in CBER’s managed review process. CBER, Biologics

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