FDA Responses to Good Clinical Practice Inquiries

The U.S. FDA addresses inquiries related to Good Clinical Practice (GCP) and human subject protection policies on an ongoing basis. The agency published responses to inquiries from 2017 to 2021 as a downloadable spreadsheet to make this information available to stakeholders in a searchable format.

Download the spreadsheet from FDA.gov

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Draft FDA Guidance for Computer Software Assurance for Production and Quality System Software

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ICH E8(R1) General Considerations for Clinical Studies