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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

Importation, Pricing Policies Raised Concerns For US FDA's Project Orbis

Allowing multi-regulator collaboration on oncology application assessment may run into pricing issues if Canada and Australia gain access to novel drugs before European countries, US FDA's Pazdur says.

Pricing Debate Drug Review

Pink Sheet Podcast: Twirla Adcom Surprise And Makena Adcom Questions

Pink Sheet reporters break down the surprising US FDA advisory committee endorsement of Twirla and the split decision on whether Makena should be withdrawn.

Advisory Committees FDA

Hahn May Not Run Into Questions About Industry Ties Like His Predecessors

Nominee for US FDA commissioner has remained largely focused on academic work and private practice, receiving only a few payments from pharma and device companies.

FDA Leadership

Stephen Hahn For US FDA Commissioner: Will Academic Experience Suffice For Confirmation?

The MD Anderson Cancer Center administrator's lack of significant government administration experience may inspire questions during the confirmation process.

FDA Leadership

Giroir Becomes Acting US FDA Commissioner, Giving Agency Experienced Political Hand

Assistant HHS secretary for health has led policy development for several offices since his 2018 confirmation and also has industry and clinical experience.

FDA Leadership

US FDA Hoping To Solve Drug-Software Issues With Digital Health Working Group

As more applications include software components, group wants assessors to apply best practices from CDRH to CDER whenever possible.

Digital Health Drug Review
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