• BIO Analysis: Resubmissions After Third Round of FDA Review Not Worth the Effort

    An analysis by the Biotechnology Industry Organization (BIO) of 748 new drug applications (NDAs) and biologics license applications (BLAs) shows a nearly 20% increase in the rate of approvals for second-round submissions in response to a first-round complete response letter (CRL). The analysis, which tracked NDA and BLA submissions made between 2005 and 2010, shows a 55% approval rate for first-round submissions. The total approval rate jumped nearly 20% to 74.6% after ...