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.
Latest From Derrick Gingery
The goal is a platform where sponsors could enter data that multiple regulators could view in real-time, rather than rely on ‘digital paper’ – pdfs and other static file formats that require health agencies to reenter the data in order to analyze it.
Several countries already are calling about orders, as the company prepares to begin a Phase III trial of its mRNA coronavirus vaccine candidate.
FDA Commissioner Hahn says industry needs to work with the agency to establish a link to more detailed supply chain information.
As agency prepares to hear from stakeholders on its strategy, real-world data precedents already are being set thanks to COVID-19, Aetion tells the Pink Sheet.
Pink Sheet Podcast: New Drug Submissions Lag, More US FDA Emergency Use Authorizations On The Way, BsUFA Revenue Misses Estimates
Pink Sheet reporter and editors discuss the lower application submission rate, another EUA for a potential coronavirus treatment, and the biosimilar user fee program missing revenue estimates again.
Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.