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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

Pink Sheet Podcast: US FDA Launches Project Orbis And The Rare Disease Cures Accelerator, Looks For Abuse-Deterrent CNS Drugs

Pink Sheet reporters discuss the US FDA's work with other countries to review and approval of cancer therapies at the same time, a new database for rare disease clinical trial and natural history data, and the agency's exploration of abuse-deterrent CNS stimulants.

Drug Review Rare Diseases

Senate Wants Priority Review For 'Deemed' Biologics Not Approved By Deadline

Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.

Biologics Legislation

Rare Disease Cures Accelerator Expected To Drive Lots Of Development – Eventually

Database is expected standardize natural history and other data collection, but won't help streamline drug development in the space for a while yet.

Clinical Trials Rare Diseases

Clinical Outcome Assessments To Be Developed Under US FDA Grants

The projects could help streamline rare disease drug development, along with the Rare Disease Cures Accelerator.

Clinical Trials Drug Review

US FDA Struggles To Meet Goals As Drug Sponsors' Meeting Requests Rise

The FDA did not expect to meet many FY 2018 goals for on-time scheduling of formal PDUFA meetings or issuing written responses in lieu of meetings.

Review Pathway FDA

Assessment Times Improve Under GDUFA

Averages likely will increase as more of the cohort is approved, however.

Generic Drugs Regulation
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