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
US FDA's Hahn Promotes Provider Role In Boosting Public Confidence In COVID-19 Products
Agency commissioner appeals to AMA audience to communicate message that FDA review decisions are based on good science.
Generic Drug Approvals Still Winning The Pandemic At US FDA
Productivity remains high as full ANDA approvals reached a FY 2020 peak and complete responses dropped to another low in June.
US FDA Clarifies: Coronavirus Vaccine Will Need Adcom Before Approval Decision
In a JAMA article, senior FDA leaders state that the outside advisers will be needed to ensure transparency given the potentially widespread use of the vaccine.
Pfizer’s Bourla Says He Feels Pressure Related To The Coronavirus Vaccine, But It’s Not Political
With the company’s vaccine candidate in Phase III, Pfizer CEO Albert Bourla says there is pressure to perform because the hopes of the world are on the pharma industry to find a solution to the coronavirus pandemic.
PDUFA Needs More Than 300 Additional FTEs, New US FDA Capacity Planning Formula Says
But the agency chose to fund only a small fraction of them, in part because of its hiring ability, and in part because all those employees would have cost an additional $98.7m in user fee revenue.
COVID-19 Demands Merit A Mention In US FDA's PDUFA Fees Notice For FY 2021
The pandemic's impact was mentioned only in FDA's calculations for fees including those established by PDUFA. In addition to prescription drug applications, PDUFA fees are charged for OTC switch applications and other proposals for ingredients that are not part of an OTC monograph to be made available nonprescription.