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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

The Last Days Of PDFs: Industry Works To Solve Its US FDA Application Problem

The goal is a platform where sponsors could enter data that multiple regulators could view in real-time, rather than rely on ‘digital paper’ – pdfs and other static file formats that require health agencies to reenter the data in order to analyze it.

Drug Review FDA

Pfizer CEO Bourla Wants Profit From COVID-19 Vaccine

Several countries already are calling about orders, as the company prepares to begin a Phase III trial of its mRNA coronavirus vaccine candidate.

Coronavirus COVID-19 Vaccines

How US FDA And Industry Are Looking To Navigate New Supply Chain Data Reporting Requirements

FDA Commissioner Hahn says industry needs to work with the agency to establish a link to more detailed supply chain information.

Coronavirus COVID-19 Manufacturing

US FDA’s Data Strategy Under Increasing Pressure From Coronavirus Pandemic

As agency prepares to hear from stakeholders on its strategy, real-world data precedents already are being set thanks to COVID-19, Aetion tells the Pink Sheet.

Coronavirus COVID-19 Real-World Evidence

Pink Sheet Podcast: New Drug Submissions Lag, More US FDA Emergency Use Authorizations On The Way, BsUFA Revenue Misses Estimates

Pink Sheet reporter and editors discuss the lower application submission rate, another EUA for a potential coronavirus treatment, and the biosimilar user fee program missing revenue estimates again.

Coronavirus COVID-19 Drug Review

CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On

Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.

Coronavirus COVID-19 Guidance Documents
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