2018 Complete Response Letters: Efficacy Issues Drove Most Product Rejections

 
• By Michael Cipriano

US FDA issued at least seven rejections to novel products; opioid analgesic sponsors had very little success, while biosimilar developers had a so-so year.

Rejected stamp

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...

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