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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

US FDA Faces Hiring Slowdown, Funding Cuts In Trump's FY 17 Plan

Suggested cuts to appropriations bill funding government for remainder of fiscal year 2017 also includes 'administrative savings.'

FDA Legislation

Abuse Deterrence: US Exclusivity Update May Ride User Fee Coattails

CDER's Woodcock suggests exclusivity rules outdated for abuse-deterrent technology development, and Rep. Griffith takes it to mean legal changes are needed.

Drug Approval Standards Generic Drugs

User Fees: Should US FDA Incur Penalties For Missed Deadlines?

Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.

Approvals FDA

FDA's No Comment On Budget Plans Leaves Awkward Void

When asked about the effect of Trump's potential cuts to FDA, agency officials are not allowed to discuss it, creating more uncertainty about the budget and user fee process.

FDA Legislation

Gottlieb's FDA: Specialized Groups Could Create Review Consistency, Speed

US FDA commissioner nominee might employ modular specialists to work with review divisions on issues related to gene therapies, molecularly-targeted drugs, adaptive clinical trial designs, or other complex issues.

Drug Review FDA

The Freeze Thaws: US FDA Allowed To Hire Staff For Cures, User Fee Activity

White House allowed agency to hire some new employees, but lawmakers remain concerned about federal hiring freeze's effect on FDA.

FDA Legislation
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