Still Time To File: Potential NDA/BLA Candidates In Queue For 2014
Potentially, 38 drugs are in queue to be filed for approval in the US before the year’s end, according to Informa’s BioMedTracker. Which drugs are the most likely candidates?
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Annual listing of novel drugs cleared by FDA’s Center for Drug Evaluation and Research.
FDA transferred review of most therapeutic biologics to the Center for Drug Evaluation & Research in 2003. The Center for Biologics Evaluation & Research continues to review other biologics, including vaccines, cellular products, antitoxins and immunoglobulins.
Even with half of CDER’s approvals qualifying for longer review timeframes under “the program,” the average time from submission to approval continued its multi-year decline, helped by a record high level of first-cycle approvals. Small molecules and big pharma dominated the 2013 class.