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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Search for FDA Guidance Documents

Draft Guidance Documents: Good Clinical Practice

Draft guidance documents have been proposed and are issued for public comment. Each FDA draft document lists how to submit comments to the agency.

The entries below are listed in reverse chronological order by publication date.

More information about draft GCP guidance documents

Draft Guidance Documents

Review and Update of Device Establishment Inspection Processes and Standards - 03/2019
A Risk-Based Approach To Monitoring of Clinical Investigations: Questions and Answers - 03/2019
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank - 09/2018
Informed Consent Information Sheet - 07/2014
Exculpatory Language in Informed Consent - 08/2011

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