Posted by Michael Wonder on 11 Apr 2022
A review of patient reported outcome labelling of FDA approved new drugs (2016-2020): counts, categories and comprehensibility
8 April 2022 - A review of new drug approvals by the U.S. FDA for 2006 to 2015 showed that approximately 20% of new drugs had labelling based on patient reported outcomes.
The purpose of this study was to review labelling text based on patient reported outcome endpoints for NDAs from 2016 to 2020, with a special focus on the comprehensibility of such statements when included.
