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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

Patient-Centered Promotion? Marathon's Non-Launch Of Emflaza Illustrates Challenge Of New Era

Can a company explain the situation surrounding a newly approved drug, including the effect of the indication on access, without violating off-label communication regulations?

Advertising, Marketing & Sales Legal Issues

Gilead Buys Its Third Priority Review Voucher, But Is The Mania Over?

Just as the tulip craze eventually subsided, it appears the pharma industry's infatuation with priority review vouchers also may be waning, as Sarepta sells its voucher for only $125m.

Financing Rare Diseases

US FDA's Drug Shortage Effort Questioned By GAO

GAO's 'high risk' report lowers FDA grade for its drug shortage action plans, saying efforts have not been sustained.

FDA Life Cycle Management

Sentinel May Expand To Generic Equivalence Studies

Tool being designed for rapid queries of US Sentinel data to consider generic drug switches, potentially spot equivalence problems.

Generic Drugs Safety

Marathon's High-Priced Window May Not Stay Open Long

Ongoing trial is intended to compare the newly approved steroid Emflaza with prednisone in DMD for efficacy and safety.

Approvals Launches

Amid Pricing Criticism, Marathon 'Pausing' Emflaza Launch

Company plans to meet with caregivers and consider other options before moving forward.

Pricing Strategies Approvals
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