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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 Tech Modernization Plan’s Costs Uncertain

Agency officials determining needs using existing budgets before requesting more funds and will engage with tech investors for design advice.

Cybersecurity Drug Review

US Generics Approvals Will Decline

With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.

Generic Drugs Regulation

US FDA Still Seeking Sponsor Cooperation For Oncology Label Updates

Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.

Generic Drugs Cancer

Generics Approvals Will Decline, US FDA Predicts, But Supplement Work May Grow

With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.

Generic Drugs Review Pathway

Opioid 'Data Warehouse' Is Part Of US FDA's New Controlled Substances Program

CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.

FDA Neurology

Oncology Center of Excellence Grows Leadership Structure, With A Vacancy Remaining

A deputy center director position remains open and four new associate director positions were added over the last year.

FDA Leadership
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