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.
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.
Database is expected standardize natural history and other data collection, but won't help streamline drug development in the space for a while yet.
The projects could help streamline rare disease drug development, along with the Rare Disease Cures Accelerator.
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.
Averages likely will increase as more of the cohort is approved, however.