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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

No More 'Hidden' Facilities, US FDA Tells Generic Sponsors

Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible for listing all facilities that could be used as part of ANDA.

Generic Drugs Review Pathway

US FDA Is Dedicating A 'Patient Affairs' Staff Without A Formal Reorg

The agency's principle deputy commissioner says it's creating a patient affairs staff, but will not undergo a reorganization.

FDA Regulation

FDA Contradicts AAM's Generic Market Consolidation Argument

As the generic industry trade group warns shortages could emerge as number of manufacturers contracts, US FDA says many new firms gaining approvals and identifying facilities.

FDA Generic Drugs

US FDA's Oncology Division Wants To Know About Your Pipeline, Not Just Your NDAs

Oncology Center of Excellence Director Richard Pazdur says agency invites sponsors to present about molecules under development to learn more about future plans.

Review Pathway Cancer

US FDA's Patient Affairs Office Is An Office … In Spirit

Rachel Sherman says agency is creating patient affairs staff, but will not undergo reorganization to create an official office.

FDA Drug Review

US FDA Drug Office Reform: 'Everything' Is On The Table

Deputy Office of New Drugs director says IND evaluation and post-market surveillance could be part of restructuring effort along with changes to application review.

Drug Review Review Pathway
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