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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

BsUFA III Talks Could Move Cloud-Platform Goals Forward

US FDA wants to use biosimilars for a demonstration of cloud-based technology, an idea mentioned to increase the use of real-time review and enhance data analysis.

Biosimilars User Fees

New Supplement Timelines, Categories Proposed For BsUFA III

The ideas could potentially address sponsor concerns about the effects of slow reviews.

Biosimilars User Fees

BsUFA III Talks Begin With Regulatory Science Disagreement

Brand trade group negotiators don’t support a biosimilar regulatory science proposal from the biosimilar and generic drug trade groups.

Biosimilars User Fees

US FDA Facility Records Review Evolved Into More Formal Process As Pandemic Continued

With more experience, the US FDA was able to standardize record review requests and timing.

Coronavirus COVID-19 Manufacturing

FDA Avoided Half Of ANDA Pre-Approval Inspections During COVID By Using Alternative Tools

Records reviews are common now in lieu of an in-person inspection for US generic applications, but more virtual facility checks could be coming soon.

Research & Development Manufacturing

BsUFA III Talks Begin With Regulatory Science Disagreement

Brand trade group negotiators don’t support a biosimilar regulatory science proposal from the biosimilar and generic drug trade groups.

Biosimilars User Fees
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