The CDRH Accreditation Scheme for Conformity Assessment pilot final report says the effort met and sometimes exceeded agency expectations.
FDA says Amneal is recalling four lots of vancomycin HCl for oral solution because some of the bottles were over-filled during the manufacturing proce...
Eugia U.S. recalls one lot of methocarbamol injection due to a customer product complaint about the presence of white particles floating inside a vial...
FDA approves a Gilead Sciences supplemental NDA for Vemlidy (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B vi...
FDA clears a Synaptive Medical 510(k) for its near-infrared fluorescence visualization module, Modus IR, adding to the existing fluorescence offering ...
FDA approves a Medexus Pharmaceuticals supplemental BLA for Ixinity [coagulation factor IX (recombinant)] for treating pediatric patients under 12 yea...
Federal Register notice: FDA withdraws approval of 30 abbreviated new drug applications from multiple applicants because the drug products are no long...
