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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

US FDA's Patient Affairs Office Is An Office … In Spirit

Rachel Sherman says agency is creating patient affairs staff, but will not undergo reorganization to create an official office.

FDA Drug Review

US FDA Drug Office Reform: 'Everything' Is On The Table

Deputy Office of New Drugs director says IND evaluation and post-market surveillance could be part of restructuring effort along with changes to application review.

Drug Review Review Pathway

'Just Say It!' – New Streamlined Guidance Format Coming, FDA's Woodcock Says

US guidances will be shorter and use a series of bullet points to communicate key ideas, replacing the current longer and wordier format.

FDA Regulation

New ANDA Review Pathways: Should You Be A Priority Or Expedited?

Amid confusion about multiple priority and expedited pathways for US generic drug applications, industry asks which are a true advantage.

Generic Drugs Review Pathway

Gottlieb: The Next Janet Woodcock Is Waiting To Be Discovered At FDA

In interview with the Pink Sheet, US FDA Commissioner says the agency needs new ways for in-house talent to more easily rise to supervisory and executive levels.

FDA Leadership

Q&A With US FDA Commissioner Scott Gottlieb

US FDA Commissioner Scott Gottlieb sat down with the Pink Sheet and Medtech Insight reporters for an exclusive chat about his ongoing regulatory work and plans for the future.

Leadership Drug Approval Standards
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