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FDA Week - 11/10/2017

But new REMS guidance draws mild response . . .

FDA Commissioner Asks Brands To 'Stop Shenanigans' Delaying Generics

November 09, 2017
FDA Commissioner Scott Gottlieb on Wednesday (Nov. 8) called on brand drug makers to "end the shenanigans" of using loopholes to delay generics, while taking a step he said will help stem brands' use of Risk Evaluation and Mitigation Strategies to put off competition. FDA released guidance aimed at streamlining talks between brands and generics on single shared REMS, and Gottlieb promised future guidance on when the agency will waive the single shared REMS requirement. He also said he would...


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