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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.

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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.

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