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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

Rare Disease Advocates Lobby US Congress For FDA Center of Excellence

Number one ask is for congressional pressure to centralize rare disease expertise at the agency, but advocates also are preparing legislation that would mandate the new center.

FDA Rare Diseases

Market For COVID-19 Therapeutics Will Exceed Government Demand, US Believes

HHS Secretary Azar says $1bn of the $2.5bn emergency supplemental funding request is for vaccine development.

Vaccines Infectious Diseases

Could Revisiting US Approval Decisions Become Less Rare?

While not identifying specific situations raising potential questions, the FDA commissioner uses his appearance at agency's annual rare disease event to advise regulatory decisions may be revisited as more data becomes available. 

Rare Diseases FDA

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
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