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01/18/2019

FDA chief: Agency has money for about 5 more weeks of drug approvals

The prolonged government shutdown is driving concerns about whether it could put the approval of new drugs in jeopardy.

Responding to a question posted on Twitter that was prompted by a report that said the agency has about three more weeks’ worth of funding to draw down after which it would have to suspend new drug approvals, FDA commissioner Scott Gottlieb said in a tweet, “We’ve stretched carryover drug user fees to get a longer runway should the shutdown continue, by for example sharply reducing any overhead charges to CDER/CBER. The slower burn rate gives us about five weeks left as of this week."

"These numbers could change, but not by more than +/- a week. We've stretched our resources by lowering burn by basically deferring internal operating charges and shifting money to salaries. We’re shifting operating dollars to payroll dollars in order to maximize our runway and preserve program functions,” Gottlieb said.
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