U.S. Food and Drug Administration

Good Clinical Practice in FDA-Regulated Clinical Trials

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Report to FDA:

Good Clinical Practice Program


Approved Products
drugs, medical devices, biologicals, animal drugs, food additives ...

Freedom of Information

Dockets Management

FDA Site Map



Guidances, Information Sheets, and Notices

Current guidance and notices on good clinical practice and the conduct of clinical trials.

Proposed Regulations and Draft Guidances

Details about these proposals and instructions for submitting comments.

Enforcement Information

Warning letters, disqualification proceedings, restricted list, adequate assurances list ...

Bioresearch Monitoring Program

Links to relevant Compliance Program Guidance Manuals and Bioresearch monitoring inspection metrics.

Educational Materials

Useful literature references, and training information about good clinical practices.

GCPP E-Mail Replies

Redacted GCPP E-mail replies to inquiries that have been submitted by the public to the Good Clinical Practice Program's gcp.questions@fda.hhs.gov E-mail account.



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