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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

US FDA Mum On Whether Woodcock Would Stick Around Long-Term For Califf

Woodcock’s willingness to stay on at US FDA for more than a transitional period after Robert Califf’s expected confirmation as commissioner may depend on exactly the type of authority and tasks he’d be willing to delegate to her. Plus, some other agency personnel updates.

FDA Leadership

Pink Sheet Podcast: Woodcock’s Legacy, Merck’s Oral COVID-19 Pill, 340B Case At Supreme Court

Pink Sheet reporters and editor review US FDA Acting Commissioner Janet Woodcock’s long career and update Robert Califf’s confirmation process, consider the advisory committee for Merck’s COVID-19 pill, and discuss an under-the-radar case on 340B policy at the US Supreme Court.

FDA Leadership

US FDA Wants Assessment Of New Drug Review ‘Culture’ Amid Modernization, Other Changes

The New Drug Review Program is seeking a contractor to survey employees on the impact of team culture on performance and overall effectiveness.

FDA Leadership

FDA Commissioner Nominee's Finances Are More Complicated In Second Confirmation Process

Robert Califf has industry connections, just like during his previous confirmation to lead the US FDA, but they are different now, as he holds several board seats in addition to a full-time position at a health care tech company.

How Star Wars Explains Biosimilar Labeling Problems

US FDA largely writes biosimilar labels that are the same as their reference products even though it’s not required, which could hinder product development and uptake, experts say.

Biosimilars Research & Development

Commissioner Nominee Reveals More Complicated Finances Ahead Of Second Confirmation Process

Robert Califf has industry connections, just like during his previous confirmation to lead the US FDA, but they are different now, as he holds several board seats in addition to a full-time position at a health care tech company.

FDA Leadership
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