US FDA Likely To Shatter Novel Approval Record In 2018
With at least 40 pending novel products, FDA seems poised to break its 2017 approval record of 46, and could even reach 60.
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In first half of 2018, CRLs were rarely issued for CDER-regulated novel agents, but FDA's rejection of Waylivra marks second in two weeks.
Keeping Track: Novel Approvals For Diacomit, Takhzyro And Oxervate; CRLs For Mallinckrodt And Allergan
The latest drug development news and highlights from our US FDA Performance Tracker.
Ten novel agents are among the pending applications with user fee goal dates in August 2018.