US FDA “Enriches” Trial Guidance With Recent Examples
Illustrating that principles articulated in 2012 draft are being broadly accepted at FDA, final guidance on enrichment strategies for clinical trials adds new examples from across the agency’s drug review divisions.
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FDA’s draft guidance on “Enrichment Strategies for Clinical Trials” fulfills an overdue goal from PDUFA IV. It also captures decades of wisdom from the agency’s senior drug review manager.
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