Derrick Gingery
Executive Editor, Reg & Policy Insights, US
Derrick focuses on the US FDA user fee programs, regulations and policy for new and generic drugs, biologics and biosimilars, advisory committee and other agency activities, as well as federal legislation and budget matters on Capitol Hill. He also hosts Pink Sheet's Pharma Regulatory Podcast. An award-winning journalist, Derrick has been a reporter for several community newspapers and a business journal. When not following FDA, Derrick is keeping close tabs on Indiana University basketball.
Latest From Derrick Gingery
INTERACT Meeting Timing Remains Point Of Confusion
US FDA review divisions will determine whether the meeting is appropriate because there are no one-size-fits-all requirements.
Pink Sheet Podcast: What’s In And Out Of US FDA’s Diversity Action Plan Guidance, AI Guidance Also Coming
Pink Sheet reporter and editors discuss what the FDA included in its long-awaited guidance on clinical trial diversity action plans, along with what was left out, as well as an upcoming guidance on the use of artificial intelligence in regulatory decision-making.
Project Optimus: Sponsors Register Concerns, Questions
Meeting requests related to the Oncology Center of Excellence’s new dose optimization approach are increasing, along with sponsor questions, prompting the US FDA to determine how to clarify its intentions.
Anti-Globalism Policy Cannot Stifle International Cooperation, US FDA’s Califf Says
The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.
US FDA Creating Rare Disease ‘Hub’ To Serve As Center Of Excellence
While not brandishing the name advocates have pushed for many years, the rare disease hub will play much the same role as a center of excellence in increasing collaboration between experts in the FDA drug and biologics centers.
PDUFA VIII: Continuous Fee Increases May Be Wearing On Sponsors
A Pfizer exec says that the old prescription drug user fee formulas that usually increase funding and staffing for many FDA programs no longer deliver the same return on investment.