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
US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.
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.
CDER Director says US FDA needs to develop statistical and other guidances faster to keep up with the pace of science and drug development.
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.
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.
Patient Engagement Collaborative expected to invite stakeholders to discuss how patient interaction with FDA can improve.