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 requirements to join the new real-time review pilot program strongly resemble those of the breakthrough designation, which could come as an unpleasant surprise for some sponsors.
System likely will evolve as post-pandemic world unfolds, but adds to list of agency programs expecting to continue using virtual platforms once in-person activities are no longer restricted by COVID-19.
Virtual meetings proved successful, and could be allowed again when the next round of user fee reauthorization talks convene.
Califf: More Expedited Approvals Mean US Clearance Only The Beginning Of Learning About Medical Products
The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.
The US FDA commissioner’s call for the agency or someone else to watch supply chains and anticipate problems sounds a lot like a generics industry idea from 2011.