Generics Bulletin is part of the Business Intelligence Division 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

Clinical Trial Reform Is A Focus For CDER's 2019 Guidance Agenda

US FDA plans new guidances on real-world data, clinical trial statistics, and patient input in coming this year.
Clinical Trials Biosimilars

CREATES Act Will Not Lead To Frivolous Lawsuits, Says AAM's Davis

Association for Accessible Medicines' Davis tries to counter concerns that the long-stalled measure would incentivize lawsuits against brand companies; witnesses at a House subcommittee hearing on drug pricing legislation also testified that the BLOCKING Act would create an overly broad and complicated framework for triggering 180-day exclusivity.

Pricing Debate Generic Drugs

CREATES Act: Republican Lawmakers Worry About Frivolous Lawsuits By Generic Firms

Association for Accessible Medicines' Davis tries to counter concerns that the long-stalled measure would incentivize lawsuits against brand companies; witnesses at a House subcommittee hearing on drug pricing legislation also testified that the BLOCKING Act would create an overly broad and complicated framework for triggering 180-day exclusivity.

Pricing Debate Generic Drugs

New Acting US FDA Commissioner Shares Agency's Clinical Trial Reform Message

Norman Sharpless, director of the National Cancer Institute, will become acting FDA commissioner when Scott Gottlieb departs.
FDA Leadership

Gottlieb Worries Vaccine Policy Could Spark Federalism Debate

Vaccination policies could result in arguments over states' rights instead of public health concerns, outgoing US FDA commissioner warns.
Vaccines Infectious Diseases

Gottlieb Wants His US FDA Team To Stay Together After He Departs

Outgoing US FDA Commissioner Scott Gottlieb doesn't want a staff shakeup at the agency upon his departure. A look at near-term leadership strategies. Also, the wait time for confirmed commissioners has been trending down.

FDA Leadership
See All
Advertisement
UsernamePublicRestriction

Register