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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

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

US FDA's Complex Trial Design Pilot May Change 'Ambitious' Timelines

Program allows eight months for sponsors to be accepted and conduct two meetings with FDA on an innovative design, but the agency said more time may be needed.
Clinical Trials Research and Development Strategies

Vocabulary Change: CDER Eliminating 'Review' For NDAs And BLAs

Like ANDA evaluations, US FDA plans to use the word assessment to describe them for NDAs and BLAs.
Drug Review FDA

EMA Restricts Sanofi's Lemtrada Use, Initiates Risk-Benefit Review

Labeling changes for the multiple sclerosis drug being mandated by European regulators were made to the US label in January.
Neurology Drug Safety
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