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Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

October 2, 2018Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

FDA issues revised guidance to allow for a more efficient approach to 505(q) petitions and focus more resources on scientific reviews.

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