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Derrick Gingery

Senior Writer

Washington, DC
Senior writer Derrick Gingery has been reporting on regulatory issues for "The Pink Sheet" and "The Pink Sheet" Daily since 2010. Among his favorite topics are FDA's user fee programs, along with generic drug and biosimilar policy, but he also handles drug approval issues and general FDA news.

An award-winning journalist, Derrick has written extensively about user fee negotiations, the FDA budget, FDA travel restrictions and drug advertising compliance. He also was part of the Pink Sheet team covering FDA's first biosimilar advisory committee meetings.

When he's not following FDA, Derrick is keeping close tabs on Indiana Hoosiers basketball.
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Latest From Derrick Gingery

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.

International United States

Checkpoint Inhibitors: US FDA Wants Consistent Adverse Event Definitions

Label writing is difficult because sponsors are collecting varying adverse reaction data, agency officials say.
Drug Safety Cancer

US FDA Wins Big In Shutdown-Averting Approps Bill

Agency would receive more than $268m in additional dollars for medical product and food safety as part of substantial FY 2019 increase.
FDA Legislation

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.
Generic Drugs Leadership

US FDA Again Looks Outside Generic Drugs Office For New Director

Sally Choe, who has been working in the Office of Translational Sciences, will take over for Kathleen Uhl in March.
Generic Drugs FDA

Combination Products: US FDA Aims For Limited Two-Application Solutions

In announcing guidance stating one application generally is sufficient for a combination product, FDA asks for comments on situations where two would be needed.
Combination Products Review Pathway
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