The Justice Department announces a plea agreement with an Alabama drug compounder charged with defrauding the Tricare military healthcare program out ...
Federal Register notice: FDA announces a 10/19 regional public meeting entitled Health Canada and U.S. Food and Drug Administration Joint Public Consu...
Federal Register notice: FDA announces an 11/6-7 Science Advisory Board to the National Center for Toxicological Research meeting.
An Alston & Bird client alert says the Supreme Court will decide whether to hear an appeal of a case that asks whether medical device manufacturers ca...
CDER opens its Direct NextGen Collaboration Portal through which industry can request pre-ANDA meetings for complex generic drug products.
FDA approves a McGuff Pharmaceuticals NDA for Ascor (ascorbic acid injection USP), a vitamin C drug product for up to one week of scurvy treatment in ...
FDA approves a Roche Molecular Systems PMA for the cobas Zika test, a qualitative nucleic acid test for detectimg Zika virus RNA in individual plasma ...
FDA approves a Mylan ANDA for glatiramer acetate injection 40 mg/mL and 20 mg/mL, AP-rated, substitutable generic versions of Tevas multiple sclerosis...