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