Swift Pace Of Accelerated Approval Submissions Suggests Strong Constituency For US FDA Program
FDA may be evaluating the future of accelerated approval, but data from the Pink Sheet’s Performance Tracker shows growth in the submissions and approvals over the past five years.
You may also be interested in...
Richard Pazdur wants the oncology community to take a fresh look at US FDA’s expedited review programs. One big question: should there be fewer of them?
Pink Sheet interactive timeline looks at key regulatory, policy and legislative developments impacting the accelerated approval pathway over the last 10 years.
Sponsors are increasingly using the accelerated approval pathway, but research continues to be critical about its aspects.