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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

NIH Ends Gene Therapy Trial Reporting Requirements In Reg Streamlining Move

Trial protocols, annual reports, and adverse event reports on gene therapies now only go to US FDA, a signal that the products can be regulated like other drugs and biologics.

Regenerative Medicine Research and Development Strategies

Sponsor-FDA Communications In IND Phase Will Get Outside Review

US FDA seeks White House approval for contacted interviews with 100 to 150 active commercial IND holders.

FDA Research and Development Strategies

Real-World Evidence Challenges: Death Among Toughest Data Points To Measure

Death typically is not included in electronic health records, and sources are disparate; Difficulties with endpoint expose potential limitation to real-world evidence use.

Clinical Trials Research and Development Strategies

US FDA's Patrick Frey Joins List Of Agency Leadership Departures

Office of New Drug's chief of staff will become Amgen's director of global regulatory policy and R&D.

FDA Leadership

Generic Review At US FDA: Record Month Completes Approval Volume Recovery

With 96 full ANDA approvals and 30 tentative approvals, July was the most productive month since GDUFA launched.

Generic Drugs Review Pathway

Paratek's Omadacycline Development May Hinge On Moxifloxacin Mortality

If moxifloxacin, the comparator in omadacycline's CABP trial, is thought to have an unusually low mortality rate, then the mortality imbalance seen between arms in the study may not seem so worrying. 

Advisory Committees Infectious Diseases
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