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
Can a company explain the situation surrounding a newly approved drug, including the effect of the indication on access, without violating off-label communication regulations?
Just as the tulip craze eventually subsided, it appears the pharma industry's infatuation with priority review vouchers also may be waning, as Sarepta sells its voucher for only $125m.
GAO's 'high risk' report lowers FDA grade for its drug shortage action plans, saying efforts have not been sustained.
Tool being designed for rapid queries of US Sentinel data to consider generic drug switches, potentially spot equivalence problems.
Ongoing trial is intended to compare the newly approved steroid Emflaza with prednisone in DMD for efficacy and safety.
Company plans to meet with caregivers and consider other options before moving forward.