Derrick Gingery
Senior Writer
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.
Latest From Derrick Gingery
Pink Sheet Podcast: Breakthrough Therapy CRLs, Statins While Pregnant, COVID-19 And Clinical Trials
Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.
Aduhelm Invades Senate Committee’s COVID-19 Hearing
Woodcock again defends the decision, saying Congress intended accelerated approval for those situations.
Wait For Stability Results Before Moving Expiring COVID-19 Vaccine, Woodcock Says
Acting FDA Commissioner Janet Woodcock says stability studies are ongoing and that states shouldn’t get rid of expiring inventory yet.
Teva Launches First-Ever CREATES Act Suit
Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.
US FDA’s Regulatory Affairs Office Building Case For More User Fee Funding
ORA represented only a small fraction of the user fee programs’ costs in recent years, but wants to show its importance to the review process.
Teva, In First-Ever CREATES Act Suit, Seeks Help With Fabry Disease Generic Development
Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.