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GUIDANCE DOCUMENT

E8(R1) General Considerations for Clinical Studies April 2022

Download the Final Guidance Document
Final
Docket Number:
FDA-2019-D-3049
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource-efficient manner. By harmonizing the regulatory expectations in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized safety reporting and marketing application submissions, and contributed to many other improvements in the quality of global drug development and manufacturing and the products available to patients.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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All written comments should be identified with this document's docket number: FDA-2019-D-3049.

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