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Derrick Gingery

Senior Writer

Washington, DC
Senior writer Derrick Gingery has been reporting on regulatory issues for "The Pink Sheet" and "The Pink Sheet" Daily since 2010. Among his favorite topics are FDA's user fee programs, along with generic drug and biosimilar policy, but he also handles drug approval issues and general FDA news.

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.

Coronavirus COVID-19 Vaccines

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.

Generic Drugs Regulation

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.

Advisory Committees Vaccines

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.

Coronavirus COVID-19 Vaccines

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.

User Fees Regulation

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.

Regulation User Fees
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