Complete response letters (CRLs) for novel products in 2018 didn't prevent the US FDA's year-end novel approval count from reaching a historic high, but a lack of evidence of efficacy appeared to be the chief culprit for new molecular entities (NMEs) and new biological entities (NBEs) being derailed.
Sponsors publicly announced the receipt of nine CRLs for novel products in 2018, more than half of which appear to...