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In response to growing concerns over drug quality in India, the government is proposing to create an electronic platform to monitor its drug supply. Read More
In a regulatory science update to Congress, the FDA cited its successes with the use of specialized consortia and improvements in clinical evaluation. Read More
Democrats in the House and Senate are seeking support for a proposal aimed at bringing down prescription drug prices — compiling ideas proposed in separate bills since the start of the year, including government negotiations and allowing importation. Read More
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