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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First-Cycle Approval Rate Already High; Can PDUFA V Actually Boost It?
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
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Broad Heart Failure Label Ushers Lexicon’s Inpefa Into SGLT2 Inhibitor Market
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