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...
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.
The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.
The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.
Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.
Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
