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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

Generic Drug Application Submission Downturn Continued In June

Approvals also plummeted, but US FDA remains on a record-breaking pace.

Generic Drugs Approvals

Pink Sheet Podcast: Mid-Year Drug Approvals, Drug Pricing Hits And Misses, A Plea For More Naloxone, And Gottlieb Goes To Pfizer

A look back at the implications of the mid-year approval total, developments in drug pricing efforts on and off Capitol Hill, the FDA's plea for generic naloxone, and former commissioner Scott Gottlieb heading to Pfizer's board of directors.
Approvals Pricing Debate

Mutual Recognition's Next Evolution May Be Sharing Info On India And China Inspections

Now that US FDA has approved the final EU authority, mutual recognition efforts could expand and deepen. Former FDA chief counsel Rebecca Wood discusses the future of approval standards harmonization in Pink Sheet interview.

Manufacturing Legal Issues

US FDA, USP Cooperate On Small Molecule Drug Monograph Updates To Speed ANDAs

Generic applicants can request monograph changes while FDA assessment is ongoing.

Generic Drugs Review Pathway

Generics Firms Race To Withdraw ANDAs

Industry consolidation may be a reason ANDA withdrawals have increased during GDUFA II.

Generic Drugs Review Pathway

US FDA Asks Sponsors Of Discontinued Naloxones To Consider Return To Market

In announcing expedited assessments for new naloxone ANDAs, the agency also offers guidance to sponsors of discontinued products considering a return to marketing.

Generic Drugs Neurology
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