HBW Insight 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

ANDA Reviews Sometimes Miss GDUFA Goal Dates To Get Quicker Approval, But How Often?

Preliminary performance data suggests only a handful of applications receiving US FDA action by the end of FY 2018 actually missed their review goals.

Generic Drugs Review Pathway

Rx Patent Reform Gets Renewed Interest From GOP As Alternative To Price Negotiation

A Republican congressman and witness discuss shortened IP protections while criticizing Nancy Pelosi's drug price negotiation plan.

Legislation Pricing Debate

US FDA Generic Approvals Break 900 Barrier In FY 2019

The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.

Generic Drugs Review Pathway

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
See All
Advertisement
UsernamePublicRestriction

Register