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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: Breakthrough Therapy CRLs, Statins While Pregnant, COVID-19 And Clinical Trials

Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.

Drug Review Clinical Trials

Aduhelm Invades Senate Committee’s COVID-19 Hearing

Woodcock again defends the decision, saying Congress intended accelerated approval for those situations.

Politics Neurology

Wait For Stability Results Before Moving Expiring COVID-19 Vaccine, Woodcock Says

Acting FDA Commissioner Janet Woodcock says stability studies are ongoing and that states shouldn’t get rid of expiring inventory yet.

Coronavirus COVID-19 Vaccines

Teva Launches First-Ever CREATES Act Suit

Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.

Legal Issues Generic Drugs

US FDA’s Regulatory Affairs Office Building Case For More User Fee Funding

ORA represented only a small fraction of the user fee programs’ costs in recent years, but wants to show its importance to the review process.

User Fees Manufacturing

Teva, In First-Ever CREATES Act Suit, Seeks Help With Fabry Disease Generic Development

Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.

Generic Drugs Legal Issues
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