CBER Novel Biologic Approvals In 2010
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Few, But Fast And On Time: 2010 Saw Low NME Count, But Almost All Were First-Cycle Approvals And FDA Met Most User Fees
The rate of first-cycle approvals of new molecular entities in 2010 eclipsed previous highs, suggesting that the regulatory innovations of the FDA Amendments Act are paying off in terms of review efficiency.
US FDA’s June User Fee Calendar Starts Out Steady, But A Crescendo Of Decisions Will Start Mid-Month
Two gene therapies and two novel inhibitors of JAK kinases are among the upcoming goal dates from the Pink Sheet’s US FDA Performance Tracker.