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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 Learns 'Lessons Of History,' Takes Opioid Fight To Gabapentinoids

Agency investigating potential misuse and abuse of gabapentinoids, which CDC had recommended as alternative to opioids, in latest twist to epidemic.
Safety Neurology

ANDA Pre-Submission Meetings A 'Challenge' To Integrate Into Development Timelines

US FDA officials appears worried about workload created by product development and pre-submission meetings for complex generics.
Generic Drugs Review Pathway

Gottlieb's Priority For Proposed Opioid Money Is Mail Facilities

US FDA commissioner says primary use of proposed budget boost would be border security; budget documents state that special opioid epidemic funding also would support regulatory science and diagnostic development.

United States FDA

Trump's Budget Surprise: FDA Gets 13% Increase

President Trump's FY 2019 budget request includes $473m in new non-user fee revenue for the US agency, a reversal of the previous year's request.

FDA Regulation

US FDA Wants To Predict ANDA Complete Response Responses

Generic industry, FDA discuss potential ways to increase transparency so agency can better estimate when – and even whether – an ANDA receiving a complete response will be returned.
Generic Drugs Complete Response Letters

US FDA Chief Gottlieb Envisions Tiered Mandates For Opioid Training System

Mandatory training could be reserved for physicians who want to prescribe opioids for longer-term use, as opposed to those who would prescribe recommended amounts in blister packs; evidence that blister packs would affect prescribing still is needed, however.
Neurology Risk Management
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