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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.
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Latest From Derrick Gingery

Biosimilar Advisory Committees Getting Smoother, Even As Worries Stay The Same

US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.

United States Advisory Committees

Hospira's Epogen Biosimilar Appears Poised For Quick Advisory Cmte. OK

US FDA will hold its first-ever half-day panel review for a biosimilar; Hopsira's epoetin, which references Amgen's Epogen, has no clinically meaningful differences despite clinical trial conduct issues and PK/PD uncertainty, agency concludes.

Advisory Committees Biosimilars

Woodcock Wants Rapid Regulatory Policy Development

CDER Director says US FDA needs to develop statistical and other guidances faster to keep up with the pace of science and drug development.

FDA Regulation

Off-Label Discussion, But No Additions, For House User Fee Bill

Several Republicans remain interested in expanding off-label communications, suggesting the issue could come up outside the user fee context, potentially as part of future drug pricing discussions.

United States Advertising, Marketing & Sales

Gottlieb Places Drug Pricing Out Front In First Speech To US FDA Staff

New FDA Commissioner tells employees that 'too many consumers are priced out of medicines they need' and that FDA must take meaningful steps to get lower cost alternatives to market.

FDA Pricing Debate

US FDA Planning Another Patient Group To Boost Involvement

Patient Engagement Collaborative expected to invite stakeholders to discuss how patient interaction with FDA can improve.

Clinical Trials FDA
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