HBW Insight 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

US FDA Appears To Have Avoided Shutdown-Related ANDA Bolus

Generic submissions were below historical norms in December and modestly higher January, meaning shutdown likely did not create a large pile of pending work.
Generic Drugs Review Pathway

Rx Spending Growth To Be Driven By New Drug Entries, CMS Says

Advances in cancer, diabetes, and Alzheimer's could lead to expensive new treatments, contributing to spending increases in next decade, according to CMS projections.
Reimbursement Pricing Debate

Rare Pediatric Disease Priority Review Voucher Not Generating New Drug Trials

Researchers find no significant difference in number of rare pediatric disease treatments starting clinical development before or after incentive was created, but advocates aren't ready to give up on the program yet.
Review Pathway Rare Diseases

Competitive Generic Therapies Get Help With Development, But Not Goal Date

Draft guidance says US FDA will try to expedite assessment of competitive generic therapy designees, but will not give shorter review goals.
Generic Drugs Guidance Documents

ANDA Sponsors In Drivers Seat For Competitive Generic Therapy Exclusivity

Draft guidance says US FDA will not assume a product has launched, the final requirement to receive the promised 180-day exclusivity, unless notified by the sponsor.
Generic Drugs Review Pathway

Nearly 9% FY 2019 Increase For FDA In Shutdown-Averting Appropriations Bill

Consolidated Appropriations Act gives FDA $5.58bn overall, 8.7% more than allocated in FY 2018. FDA received $268.8m in additional budget authority and $178.3m in additional user fee funds. FY 2019 funding would have lapsed Feb. 16 and another government shutdown would have started if President Trump didn't sign the bill on Feb. 15.

International United States
See All
Advertisement
UsernamePublicRestriction

Register