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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

Amid Hype Over Narcan First Generic, A Plea For A Labeling Change

Naloxone distribution programs ask that the cheaper generic injectable formulation have the same community-use language in its label as the nasal spray and auto-injector so they can maximize their distribution efforts.
FDA Neurology

Rounding Up And Down: Assessing FDA FY 2019 and FY 2020 Workload Estimates

US FDA provides a few hints about upcoming industry application filing volume and the agency's assessment pace in FY 2020 budget documents.
Review Pathway FDA

US FDA's Submission And Review Estimates For 2020

US FDA's FY 2020 budget request include estimates of new, generic and OTC drug reviews and approvals, although some estimates may not represent the agency's expectations.
Review Pathway FDA

Acting FDA Chief Sharpless Pledges 'Full Speed Ahead' On Current Agenda

In his first speech to agency staff, Acting Commissioner Norman Sharpless says FDA will continue working on issues including food safety and nutrition drug, and he is not approaching the post like a temporary caretaker. Sharpless said his appointment does not reflect attempt by President Trump or HHS Secretary Alex Azar to force FDA to change direction set by Scott Gottlieb.

FDA Regulation

'Full-Speed Ahead,' Says Acting US FDA Chief Sharpless

In his first speech to agency staff, US FDA acting Commissioner Ned Sharpless says the agency will continue working on issues such as the Medical Device Safety Action Plan, the precertification program and the National Evaluation System for health Technology (NEST). He also says he's not approaching the post like a temporary caretaker.

FDA Leadership

Acting US FDA Chief Sharpless Pledges "Full Speed Ahead" On Agency's Current Agenda

In his first speech to agency staff, Acting Commissioner Norman Sharpless says FDA will continue working on issues including drug pricing and opioids – and he is not approaching the post like a temporary caretaker. 
FDA Leadership
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