CDRH Office of Device Evaluation regulatory advisor Joshua Silverstein leaves FDA for an undisclosed private sector job.
FDA warns Nixa, MO-based Aire-Master of America about CGMP and other violations in its manufacturing of two hand sanitizers.
CDRH director Jeff Shuren says that life after Covid-19 at the Center could greatly benefit from more regulatory flexibility, which was critical in ge...
FDA approves a GSK BLA for Priorix (measles, mumps and rubella vaccine) for use in individuals 12 months of age and older.
Bristol Myers Squibb withdraws a supplemental BLA for Reblozyl (luspatercept-aamt) for treating anemia in adults with non-transfusion dependent beta t...
The Washington State Supreme Court rules that doctors, and not drug companies, bear responsibility to warn patients about potential adverse events whe...
FDA classifies as Class 1 a Philips Respironics recall of all V60 and V60 Plus ventilators because an internal power fluctuation may cause the ventila...
Federal Register notice: FDA withdraws its guidance entitled Effects of the Covid-19 Public Health Emergency on Formal Meetings and User Fee Applicati...