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Generic Industry Once Again Must Get To Know New US FDA Office Director

Executive Summary

Incoming Office of Generic Drugs Director Sally Choe is largely unfamiliar to industry, but potentially offers a new perspective.

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Next US FDA Generics Leader Must Have ‘Frank Conversations’ With Colleagues, Industry, Former OGD Director Says

Susan Rosencrance, who helped negotiate GDUFA III, will take over as acting director of the Office of Generic Drugs following Sally Choe’s departure on 8 October. Former OGD head Uhl says the director needs to be the ‘number one advocate for the generic drug program inside the agency.’

US FDA's 'Great' Generic Approval Engine Can Be Better, New OGD Director Says

In interview with the Pink Sheet, Sally Choe expresses doubts that setting goals for approval totals is productive, saying the current workflow looks fine.

Nearly 9% FY 2019 Increase For FDA In Shutdown-Averting Appropriations Bill

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.

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