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Federal Register notice: FDA seeks comments on an information collection for Class II Special Controls Guidance Document: Labeling...[ Price : $8.95]
Federal Register notice: FDA announces an 11/30 to 12/1 Blood Products Advisory Committee advisory committee meeting.[ Price : $8.95]
Insys Therapeutics asks FDA not to approve any ANDA for generic Syndros based on an agency waiver of bioequivalence testing.[ Price : $8.95]
FDA publishes a guidance to help drug sponsors evaluate the effects of psychoactive drugs on the ability to operate a motor vehicl...[ Price : $8.95]
Federal Register notice. FDA makes available a draft guidance for industry on Use of a Drug Master File for Shared System REMS Sub...[ Price : $8.95]
FDA approves Mercks Prevymis (letermovir) once-daily tablets for oral use and injection for intravenous infusion, indicated for pr...[ Price : $8.95]
FDA clears a DT MedTech 510(k) for its Hintermann Series H2 Total Ankle Replacement System.[ Price : $8.95]
CDER issues a MAPP detailing how generic drug ANDAs, amendments, and supplements will be prioritized for review.