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.
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Latest From Derrick Gingery
Allowing multi-regulator collaboration on oncology application assessment may run into pricing issues if Canada and Australia gain access to novel drugs before European countries, US FDA's Pazdur says.
Pink Sheet reporters break down the surprising US FDA advisory committee endorsement of Twirla and the split decision on whether Makena should be withdrawn.
Nominee for US FDA commissioner has remained largely focused on academic work and private practice, receiving only a few payments from pharma and device companies.
The MD Anderson Cancer Center administrator's lack of significant government administration experience may inspire questions during the confirmation process.
Assistant HHS secretary for health has led policy development for several offices since his 2018 confirmation and also has industry and clinical experience.
As more applications include software components, group wants assessors to apply best practices from CDRH to CDER whenever possible.