The owner of a Utah drug distribution company pleads guilty in southern New York federal court to fraudulently distributing more than $100 million wor...
PTC Therapeutics says it plans to file in protest an NDA for Translarna (ataluren) for treating nonsense mutation Duchenne muscular dystrophy this qua...
FDA accepts for priority review a Genentech supplemental BLA for Tecentriq (atezolizumab) for treating certain people with locally advanced or metasta...
An analysis by the law firm Mintz Levin finds data integrity was a top concern for FDA In 2016, and it examines other enforcement trends.
Federal Register Notice: FDA extends the comment period for a revised draft guidance entitled Submission of Quality Metrics Data that was published in...
Federal Register Notice: FDA announces a 3/23 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting to review Claret Medi...
Federal Register Notice: FDA announces an Emergency Use Authorization issuance to ELITechGroup Molecular Diagnostics for an in vitro diagnostic device...
Federal Register Notice: FDA seeks information and comments about how it plans to administer generic drug program fees beginning in fiscal year 2018 (...