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Clinical holds

This article was originally published in The Tan Sheet

Executive Summary

Sponsors of INDs "may not proceed with a clinical trial on which a clinical hold has been imposed until the sponsor has been notified by FDA that the hold has been lifted," a proposed rule published in the Dec. 14 Federal Register states. In the same issue, FDA also publishes the final rule on clinical holds, as mandated by the FDA Modernization Act, which requires the agency to review the clinical hold within 30 days of a sponsor's written request to do so, if complete responses to issues of the hold have been addressed. The requirement that sponsors not proceed with a trial until notified by FDA is regardless of the 30-day rule. FDA described the definition of complete response its May 14 guidance "Submitting and Reviewing Complete Responses to Clinical Holds"

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