FDA describes progress to date on its project to identify and prioritize pharmaceutical quality/chemistry, manufacturing, and controls (PQ/CMC) information that would benefit from a structured submission approach.
FDA says Magellan Diagnostics is again distributing its LeadCare II blood test that had been part of a 2021 recall for a significant risk of falsely low results.
ORA Office of Pharmaceutical Quality Operations director Alonza Cruse says FDA is prioritizing inspections of firms with the highest risk of finding compliance issues, including those that may have data integrity concerns.
Medtronic recalls a subset of IN.Pact Admiral and IN.Pact AV paclitaxel-coated percutaneous transluminal angioplasty balloon catheters due to the potential for pouch damage and a resulting loss of sterility.
FDA says patients and healthcare professionals should not use drugs purporting to be sterile produced by Richardson, TX-based FarmaKeio Superior Custom Compounding.