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Revised draft guidance aligns petition, application reviews . . .

FDA To Alert FTC, Congress If Citizen Petitions Used To Delay Generics

October 04, 2018
FDA warned brand drug makers Tuesday (Oct. 2) that it will alert the Federal Trade Commission (FTC) and Congress if it determines that a citizen petition was submitted primarily to delay approval of a generic drug application. The warning is tucked into a revised draft guidance that also aligns petition review dates with user fee review goal dates as part of FDA's revved-up effort to curb the use of citizen petitions to delay generics or biosimilars from coming onto the...