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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

Drug Review Times Are Not Shortened Much By Single Expedited Review Designation

Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.

Drug Review FDA

US FDA User Fee Renewals Remain On Schedule Despite Coronavirus

Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.

User Fees Drug Review

US FDA And Sponsors Resolve Disclosure Issues On Complex Trial Design Pilot Projects

Agency officials can now discuss the ideas that have been accepted, though not in great detail.

Clinical Trials Research and Development Strategies

US FDA Exploring Virtual Advisory Cmtes.; Might Sponsors Want To Wait For In-Person Meetings?

Likelihood of webcast-only advisory committee meetings may depend on the extent of the coronavirus outbreak, Office of New Drugs Director Peter Stein tells the Pink Sheet in an interview.

Coronavirus COVID-19 Advisory Committees

Coronavirus Sponsors Should Get Responses To Regulatory Requests Within One Day, US FDA Says

As part of the new Coronavirus Treatment Acceleration Program, FDA staff also are being reassigned to handle investigational therapy requests faster.

Coronavirus COVID-19 Drug Review

Coronavirus Demanding Focus Of US FDA’s Antiviral, Other Divisions

Office of New Drugs Director Peter Stein said in an interview that a large amount of coronavirus-related work is arriving at the FDA, but so far staff are keeping up.

Coronavirus COVID-19 Drug Review
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