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
US FDA seeks White House approval for contacted interviews with 100 to 150 active commercial IND holders.
Death typically is not included in electronic health records, and sources are disparate; Difficulties with endpoint expose potential limitation to real-world evidence use.
Office of New Drug's chief of staff will become Amgen's director of global regulatory policy and R&D.
With 96 full ANDA approvals and 30 tentative approvals, July was the most productive month since GDUFA launched.
If moxifloxacin, the comparator in omadacycline's CABP trial, is thought to have an unusually low mortality rate, then the mortality imbalance seen between arms in the study may not seem so worrying.
Most FDA advisory committee members say potential mortality issue seen in community acquired bacterial pneumonia patients can be addressed postmarket.