Posted by Michael Wonder on 07 Oct 2022
Fulfilment of post-market commitments and requirements for new drugs approved by the FDA, 2013-2016
3 October 2022 - Pre-approval trials of investigational drugs have limited duration and size and often exclude certain populations.
Furthermore, the US FDA has recently approved drugs based on fewer clinical trials or less rigorous study designs than in previous years through increased use of expedited pathways and often instructs manufacturers to conduct post-approval studies, which may be delayed or incomplete.
Because data are lacking about the timeliness of post-approval studies for new drugs approved after 2012, we studied 2013-2016 approvals with follow-up through the end of 2020.
