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A broad group of industry organizations is urging the FDA to delay its quality metrics reporting program, which would require drugmakers to aggregate information on the number of lots started, released for distribution and found out-of-specification, as well as the number of quality complaints reported. Read More
The FDA issued a complete response letter Wednesday to Mylan for its generic version of the Advair Diskus asthma inhaler developed by GlaxoSmithKline. Read More
An FDA advisory committee unanimously voted to recommend approval of Genentech’s new subcutaneous formulation of Rituxan for several blood cancer indications. Read More
FDA Commissioner nominee Scott Gottlieb will recuse himself for one year from decisions relating to more than 20 companies, including large drugmakers, according to his ethics disclosure form. Read More