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FDA commissioner Scott Gottlieb says a revised draft guidance should improve the predictability and efficiency of generic drug reviews by addressing c...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Federal Register notice: FDA issues a draft guidance entitled The Special 510(k) Program.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