Medtech 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 Outlines Streamlined Development Path For Targeted Therapies

But reminds sponsors that more trials could be ordered post-approval, which may be important in face of evidence that tissue-agnostic cancer therapies are not always equally effective.

Research and Development Strategies Cancer

Generic Labeling Rule Dies In Latest Reg Agenda, But Electronic Labeling Is Reborn

US FDA also indicated plans to update definition of biologic product and propose a one-page Patient Medication Information in the latest Unified Agenda.

Regulation FDA

Mandatory Provider Training For Opioids Embraced By PhRMA

Trade association members also commit tens of millions of dollars to set up addiction prevention programs and create new health care tools.

Neurology Policy

Opioid Packaging: Is Non-Inferiority Enough For A New Claim?

Industry exec suggests new packages need be merely no worse than the classic amber vial to gain a claim, but US FDA says packaging intended to fight abuse should be better.

Review Pathway Innovation

Complete Response Letters: Firms See Value In Public Release, Don't Expect It Will Happen

One industry CEO says it would on net be beneficial even though some companies would suffer if they were made public.

Complete Response Letters Drug Review

Opioid Packaging Standards Could Emerge From Dosage Guidelines in Labeling

US FDA wants to work with practitioners to develop suggested prescribing standards, which could then be used to create packaging requirements.

FDA Generic Drugs
See All
Advertisement
UsernamePublicRestriction

Register