The proposed rule undermines the 'sameness' requirement in Hatch-Waxman and will result in situations where multiple FDA-approved, therapeutically equivalent products will have different safety-related labeling.
Pitts criticizes a proposed FDA rule affecting generic drug labeling.
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The time of 10 o'clock having arrived, I will call this subcommittee meeting to order.
I am very pleased to congratulate and welcome my good friend, Dwight Evans, to the floor of the House. Before I served here in Congress for the last 20 years, I served in the statehouse of Pennsylvania for 24 years. In the last 8 years of…
The recent events in Orlando, Paris and San Bernardino remind us of the very real threat of mass casualty events.
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