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FDA gives Pfizer traditional approval for its previously accelerated-approved Tivdak (tisotumab vedotin-tftv) for recurrent or met...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled FDA Recall Regulations 21 CFR Part 7....[ Price : $8.95]
Federal Register notice: FDA announces a 6/13 virtual public meeting entitled Listening Session: Optimizing FDAs Use of and Proces...[ Price : $8.95]
FDA warns the UKs Spectrum Medical about QS violations in its production of unapproved perfusion system devices.[ Price : $8.95]
BioMrieux recalls its VITEK 2 AST antimicrobial sensitivity testing cards due to a higher concentration of ceftriaxone antibiotic ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft document entitled Considerations for the Use of Human- and Animal-Derived Mat...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Content and Format of Composition Statements in NDAs and AN...[ Price : $8.95]
FDA plans a 6/13 listening session as part of its plan to revamp the use of advisory committees.