Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Advertisement
Set Alert for Articles By Derrick Gingery

Latest From Derrick Gingery

US FDA's GDUFA-Related FTEs Increase … Except In CBER

Employees performing generic drug user fee program and related work increased nearly 68% between FY 2014 and FY 2018; Costs, as well as dependence on fees to pay for them, also increased during the period.

Review Pathway Generic Drugs

FDA Fights Problems With Pre-ANDA Meeting Requests

More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.

Regulation Generic Drugs

US FDA Still Fighting Problems With Pre-ANDA Meeting Requests

More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.

Drug Review Generic Drugs

FDA Reports Millions In Unpaid GDUFA Fees

The $20m in generic drug user fee receivables was 12% of the estimated total to be collected in 2018.

Regulation Generic Drugs

BIO Stalwart Greenwood Announces Departure

Long-time CEO of the Biotechnology Innovation Organization will remain until after the 2020 election and help with the leadership transition.

Leadership Pricing Debate

US FDA Reports Millions In Unpaid GDUFA Program Fees

The $20m in generic drug user fee receivables was 12% of the estimated total to be collected in 2018.

Generic Drugs Review Pathway
See All
Advertisement
UsernamePublicRestriction

Register