Gottlieb acts on promise to Congress . . .

FDA Plans Generic Competition Meeting, Seeks Input on REMS, Pay-For-Delay

June 22, 2017 at 3:52 PM
FDA Commissioner Scott Gottlieb is acting on his promise to congressional appropriators that the agency will hold a public meeting examining potentially anti-competitive actions meant to keep generics off the market. In preparation for that meeting, set to be held July 18, FDA is asking for public comment on how the agency can tackle abuses of Risk Evaluation and Mitigation Strategies, patent evergreening and pay-for-delay agreements, among others. Gottlieb says public input will help shape the agency's Drug Competition Action...


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