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
Horizon CEO says safety trial will be conducted in a larger patient population following discussions during the US FDA advisory committee meeting.
US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.
December's ANDA rush has provided the largest monthly haul in two years. However, the month may be losing its influence over the US FDA's annual submission total.
US FDA's advisors produce tie vote on bupivacaine extended-release solution for post-surgical analgesia; proponents valued its potential to to cut opioid use, while opponents questioned its efficacy.
However, the month may be losing its influence over the US FDA's annual submission total.