Generic Industry Once Again Must Get To Know New US FDA Office Director
Incoming Office of Generic Drugs Director Sally Choe is largely unfamiliar to industry, but potentially offers a new perspective.
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In interview with the Pink Sheet, Sally Choe expresses doubts that setting goals for approval totals is productive, saying the current workflow looks fine.
Consolidated Appropriations Act gives FDA $5.58bn overall, 8.7% more than allocated in FY 2018. FDA received $268.8m in additional budget authority and $178.3m in additional user fee funds. FY 2019 funding would have lapsed Feb. 16 and another government shutdown would have started if President Trump didn't sign the bill on Feb. 15.
Agency would receive more than $268m in additional dollars for medical product and food safety as part of substantial FY 2019 increase.