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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

ANDA Approval Records Will End As US FDA Mops Up Backlog

CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.

Generic Drugs Review Pathway

Commissioner Nominee's Required Divestitures Illustrate US FDA's Broader Recruitment Challenge

Stephen Hahn will have over 100 stocks to divest upon becoming FDA commissioner.

FDA Leadership

Missed ANDA Nods Mostly Due To 'Imminent Approval'

US FDA will miss goal dates to reach speedier generic drug application approvals, but says decisions will be case by case.

Regulation Review Pathway

ANDA User Fee Misses Are Mostly Part Of 'Imminent Approval' Process

US FDA will miss goal dates to reach speedier generic drug application approvals, but says decisions will be case by case.

Review Pathway Generic Drugs

US Complex Generics Need New Communication Channels

US FDA and complex generic sponsors need a way to talk about reference product and other changes once the pre-submission meetings pathway is exhausted.

Generic Drugs Regulation

Complex Generics May Need New Communications Options In GDUFA III

US FDA and complex generic sponsors need a way to talk about reference product and other changes once the pre-submission meetings pathway is exhausted.

Generic Drugs Drug Review
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