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FDA Cannot Accept Most Generic Drug Applications During Shutdown

January 08, 2019
FDA Commissioner Scott Gottlieb reiterated over the weekend (Jan. 5 and 6) that the agency will not accept any new abbreviated new drug applications for generic drugs during the government shutdown, and said that funding to review some pending brand-drug and biologic applications will run out in about a month. If the shutdown stalemate continues, the pause in drug approvals could delay generic competition. “If FDA isn’t accepting any new applications and dates come up for the first generic filers,...


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