FDA Cannot Accept Most Generic Drug Applications During Shutdown

By Rachel Cohrs / January 8, 2019 at 2:13 PM
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,...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.