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Derrick Gingery
Senior Writer
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.
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.
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.
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.
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.
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.