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
Approvals also plummeted, but US FDA remains on a record-breaking pace.
Pink Sheet Podcast: Mid-Year Drug Approvals, Drug Pricing Hits And Misses, A Plea For More Naloxone, And Gottlieb Goes To Pfizer
Now that US FDA has approved the final EU authority, mutual recognition efforts could expand and deepen. Former FDA chief counsel Rebecca Wood discusses the future of approval standards harmonization in Pink Sheet interview.
Generic applicants can request monograph changes while FDA assessment is ongoing.
Industry consolidation may be a reason ANDA withdrawals have increased during GDUFA II.
In announcing expedited assessments for new naloxone ANDAs, the agency also offers guidance to sponsors of discontinued products considering a return to marketing.