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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

Patient Warehousing Emerges As Another COVID-19 Vaccine Confidence Problem

CDC officials designing distribution plans worry some eligible for vaccination may wait for a better product to emerge.

Vaccines Coronavirus COVID-19

Where The COVID Vaccine Trials Stand: A Snapshot Of The Leaders And Rest Of The Field

With some studies about to finish and others on clinical hold, the coronavirus vaccine field approaches an inflection point as the US FDA prepares for its first advisory committee on the topic. Our charts and graphics offer a quick look at what stands where.

Clinical Trials Coronavirus COVID-19

Upcoming COVID Vaccines Cmte. May Be More For Public Education Than Advising US FDA

Agenda for Thursday’s meeting on coronavirus vaccine development and approval includes lots of background, which may help public confidence, but not necessarily FDA assessors as they weigh the tough decisions ahead of them.

Vaccines Coronavirus COVID-19

COVID Vaccine Postmarket Monitoring Will Depend On Which Adverse Events US FDA Wants To Watch

US FDA has the unenviable task of picking the most important adverse events to track once coronavirus vaccinations begin; CDC's list will need to be winnowed to 10-20 to make the surveillance feasible, and which AEs make the cut may be informed by the vaccine trials, as well as clinical experience with COVID infections.

Coronavirus COVID-19 Vaccines

Woodcock's Prophesy Comes True: US FDA ANDA Approvals Decline From Record Levels

Janet Woodcock’s 2019 prediction that record ANDA approval volumes would not continue is confirmed with the FY 2020 approval total down 21% from the previous year.

Generic Drugs FDA

COVID-19 Vaccines: Lost Placebo Control Could Mean Lost Approval, US FDA Officials Say

Getting an EUA is not a reason to vaccinate all placebo patients, US FDA officials write in NEJM article.

Coronavirus COVID-19 Vaccines
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