The U.S. Food and Drug Administration (FDA) issued a draft guidance today for Adaptive Designs for Medical Device Clinical Studies. The document provides guidance on how to plan and implement adaptive designs for clinical studies that allow for prospectively planned modifications based on accumulating study data without undermining the integrity and validity of a trial.
Read the full draft guidance here
Compliance News: A blog on regulatory compliance and quality assurance topics, including current Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
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