Food and Drug Administration - Documents

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A selection of documents from the Food and Drug Administration (FDA)

FDA: Establishment and Operation of Clinical Trial Data Monitoring Committees – 2006

​FDA: Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials – 2010

FDA: Guidance for Industry: Non-Inferiority Clinical Trials (draft) – 2010

​FDA: Guidance for Industry: Clinical Trials with Adaptive Designs (draft) – 2010