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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

Trial Dropouts Illustrate Worries For J&J, Other Later Entrants To COVID Vaccine Space

More than 5% of participants in J&J’s vaccine trial chose to be unblinded because they were eligible to receive a vaccine that had already gained a US FDA emergency use authorization.

Clinical Trials Advisory Committees

PDUFA VII Could Expand US Real-Time Review Beyond Oncology

A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.

User Fees Drug Review

Pandemic Taking Its Toll On The US FDA’s Non-Pandemic Work, Alkermes CEO Says

Last year was not the greatest performance by the agency outside of COVID-19, Richard Pops tells BIO conference.

Coronavirus COVID-19 Advisory Committees

Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload

Pink Sheet reporters and editor discuss the issues surrounding an FDA warning letter on Dsuvia promotion, an expected jump in CDER coronavirus-related workload, and a study of refuse-to-file actions.

Coronavirus COVID-19 Review Pathway

PDUFA Renewal Negotiations Nearly Complete, With CBER Slated For Major Resource Increase

While the prescription drug user fee agreement between industry and the US FDA is almost done, generic renewal talks remain ongoing, and biosimilar talks have not started.

User Fees Drug Review

US FDA Could Be Facing Bolus Of Pandemic-Related Applications

Acting CDER Director Cavazzoni says it is ‘a very active time’ as many clinical trials for COVID-19-related products are expected to read out soon.

Coronavirus COVID-19 Drug Review
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