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Pediatric Study Compliance Could Face Scrutiny In PDUFA Renewal

Executive Summary

FDA says compliance is on par with other postmarketing requirements, but jury is still out on whether public posting of noncompliance letters has been effective tool to ensure timely trial completion.

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Opioid Studies In Children Still Facing Design Challenges

FDA cites Purdue and Mallinckrodt over required assessments for Dilaudid and Xartemis XR, respectively; Merck also draws letter for failing to timely submit a PREA study labeling change for the antibiotic Cubicin.

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