The CDER Office of New Drugs says it participated in 55 novel drug approvals in 2023.
FDA gives Pfizer traditional approval for its previously accelerated-approved Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical can...
Federal Register notice: FDA sends to OMB an information collection extension entitled FDA Recall Regulations 21 CFR Part 7.
Federal Register notice: FDA announces a 6/13 virtual public meeting entitled Listening Session: Optimizing FDAs Use of and Processes for Advisory Com...
FDA warns the UKs Spectrum Medical about QS violations in its production of unapproved perfusion system devices.
BioMrieux recalls its VITEK 2 AST antimicrobial sensitivity testing cards due to a higher concentration of ceftriaxone antibiotic in two wells.
Federal Register notice: FDA makes available a draft document entitled Considerations for the Use of Human- and Animal-Derived Materials and Component...
SonarMed recalls its SonarMed Airway acoustic ventilator sensors due to a restricted inner diameter of the device resulting in difficulty passing a su...
