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FDA warns Datascope Corp. about Quality System and Medical Device Reporting violations in its manufacturing of several medical dev...[ Price : $8.95]
FDA commissioner Scott Gottlieb says a revised draft guidance should improve the predictability and efficiency of generic drug rev...[ Price : $8.95]
Federal Register notice: FDA announces an 11/8 Vaccines and Related Biological Products Advisory Committee meeting to hear an over...[ Price : $8.95]
Eli Lilly plans to submit an NDA for Ultra Rapid Lispro in 2019 after reporting favorable clinical trial data from two Phase 3 tri...[ Price : $8.95]
Federal Register notice: FDA issues a draft guidance entitled The Special 510(k) Program.[ Price : $8.95]
Federal Register notice: FDA issues an order to debar Richard M. Fleming for 10 years from providing services in any capacity to a...[ Price : $8.95]
FDA warns N-Molecular about CGMP violations in its production of PET drugs.[ Price : $8.95]
FDA posts a guidance entitled Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.