Generics Bulletin 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

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

US FDA Publishes, Then Withdraws, PDUFA Rates Because Process ‘May Not Be Well Understood’

User fees for FY 2021 were set to increase nearly 11%, but could have gone even higher; a new notice will be issued but timing is unclear.

User Fees Review Pathway

ANDA Approval Decline Continues, But Why?

US FDA says COVID disruptions may be having an impact; complete response letters have also dropped significantly.

Generic Drugs Review Pathway

US FDA Doesn’t Need Conditional Approval Pathway, Cavazzoni Tells House Committee

CDER director says agency has many tools to expedite development and does not endorse adding a pathway similar to EU’s conditional approval. Neurodegenerative diseases hearing in Energy & Commerce Committee focuses more on ALS than Aduhelm.

Neurology Politics

FDA Rebates Biosimilar Fees And Limits Generic Fee Hike

The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.

User Fees Generic Drugs

US FDA Rebates Biosimilar Fees, Limits Generic Fee Hike In FY 2022

The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.

Biosimilars Generic Drugs

US FDA Seeking New Orphan Products Office Director Amid Internal Moves

OOPD’s deputy director has been named the acting head of the office responsible for orphan and rare pediatric disease designations.

Rare Diseases Leadership
See All
UsernamePublicRestriction

Register

;