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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.

Latest From Derrick Gingery

Pink Sheet Podcast: Adcoms Too Emotional, Pushing Gene Therapy Science, Congress Gets UFA Update

Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.

Advisory Committees Gene Therapy

Will COVID Finally Help US FDA And Sponsors Overcome Their ‘Angst’ On Innovative Trial Designs?

The ‘sea change’ inside White Oak should be seen as very encouraging for sponsors, FDA official says.

Clinical Trials Coronavirus COVID-19

Domestic In-Person Inspection Work Could Be Back To Normal This Summer, Woodcock Says

Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.

Coronavirus COVID-19 Manufacturing

Congress Already Preparing For User Fee Bills

Multiple congressional offices attended a briefing on GDUFA III with FDA and industry officials, suggesting plans for the must-pass bill already are in the works.

User Fees Generic Drugs

COVID-19’s Damage To Gene Therapy Development May Last Years

US FDA's Peter Marks says the field is robust, but hedges on approval predictions for the coming years because of pandemic’s effect.

Regenerative Medicine Research and Development Strategies

Alzheimer’s Can Follow HIV And Become Chronic Condition If Science Advances, Woodcock Argues

The acting US FDA commissioner equates drug development in the neurodegenerative diseases to work on HIV.

Neurology Research and Development Strategies
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