Will FDASIA Slow Things Down?
During Elsevier Business Intelligence’s FDA/CMS Summit in December, FDA Office of New Drugs Director John Jenkins discussed the possible impact of the FDA Safety and Innovation Act, as compared to the significant burden posed by implementation of the 2007 FDA Amendments Act.
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FDA official says the rate of approving applications in the first review cycle may not increase much more, even as the new review model, intended to promote more first-cycle approvals, has yet to finish with its inaugural applications.
PDUFA Performance In The FDAAA Era: Over One Third Of Novel 2009 CDER Approvals Took Advantage Of Relaxed User Fee Goal Interregnum
CDER met the user fee goals of almost two-thirds of new molecular entities and novel therapeutic biologics approved in 2009, even at the height of the almost two-year period when Office of New Drugs Director John Jenkins allowed reviewers to miss Prescription Drug User Fee Act action dates due to workload and resource constraints
Novel agents approved under Real-Time Oncology Review posted a median time to approval of seven months, our Pink Sheet RTOR infographic shows, while other RTOR applications had a median 4.5 month approval time.