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2017 Complete Response Letters: Fewer Than 2016, Still More Than Years Past

 
• By Michael Cipriano

US FDA's complete response letters dropped from 41 in 2016 to 30 in 2017; quality issues as share of total letters continued to climb.

Pink Sheet Perspectives 2017 - 2018

After a record-setting year of complete response letters issued by the US FDA in 2016, product rejections dropped off to 30 in 2017, a 27% decrease from the 41 disclosed the previous year.

Complete response letters for new molecular entities (NME) and new biological entities (NBE) significantly decreased as a share of total complete responses. In 2016, complete responses for NMEs and NBEs comprised 41% of total letters

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