GUIDANCE DOCUMENT
E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES August 2019
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2019-D-3049
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
Clinical studies of medical interventions are conducted to provide information that can ultimately improve access to safe and effective drugs with meaningful impact on patients, while protecting those participating in the studies. This document focuses on designing quality into clinical studies, considering the diversity of clinical study designs and data sources used to support regulatory and other health policy decisions.
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All written comments should be identified with this document's docket number: FDA-2019-D-3049.