Posted by Michael Wonder on 14 Dec 2020
Public posting of a comprehensive surrogate endpoint table for CDER and CBER regulated products
11 December 2020 - The public posting of a surrogate endpoint table for both reasonably likely and validated surrogate outcomes was mandated by the 21st Century Cures Act of 2016 and was achieved in July 2018.
The table increases transparency by informing stakeholders about the development of novel surrogate endpoints/outcomes.
It also provides consistency in the application of existing outcomes to drug development programs, thus expediting drug development according to comprehensive criteria.
