JAMA Study Continues Wave Of Accelerated Approval Criticism Amid Expansion Of Pathway
Sponsors are increasingly using the accelerated approval pathway, but research continues to be critical about its aspects.
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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.
Pink Sheet interactive timeline looks at key regulatory, policy and legislative developments impacting the accelerated approval pathway over the last 10 years.
Former US FDA Commissioner Scott Gottlieb said that despite the $500m Lilly took in from sales of Lartruvo, the company probably lost money with the costs of R&D and withdrawing the drug from the market.