FDA has about one month of user fee funds left, Gottlieb warns
As the House preps to take action on individual appropriations bills this week, including one that will fund the FDA, Commissioner Scott Gottlieb has further clarified what the agency has left in user fee funds, what review activities will take place and how the agency is helping its employees conduct inspections.
Due to the partial shutdown, the FDA cannot accept new 2019 user fees, which means the agency cannot accept new medical product applications unless they are user-fee-program related but don’t require the payment of a user fee, which is “a very small subset of applications,” Gottlieb noted.
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