Opioid Studies In Children Still Facing Design Challenges

11 Aug 2016

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.

Opioid study design issues underlie two of the three publicly disclosed noncompliance letters that FDA has issued in 2016 for Pediatric Research Equity Act (PREA) postmarketing requirements.

In an April 21 letter, the agency notified Purdue Pharma LP that it failed to timely submit...