CBER issues “independent consultant” guidance
This article was originally published in The Gray Sheet
Executive Summary
FDA draft guidance, "Independent Consultants for Biotechnology Clinical Trial Protocols," announced in a 1May 7 Federal Register notice, outlines qualification criteria for participation in the PDUFA III user fee program allowing FDA-approved independent consultants to review clinical protocols for breakthrough biotech products. Comments on the Level 1 guidance are due by Aug. 5...
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