CBER finalized two guidance documents on regenerative medicine therapies. Drafts of the two were issued in November 2017 as part of the regenerative medicine policy framework. One guidance addresses the evaluation of devices used with products designated as “regenerative medicine advanced therapies” (RMATs). The second guidance addresses expedited programs for regenerative medicine therapies for serious conditions, including the “breakthrough” and RMAT programs.
[/membership][membership level=”0,4″][The content continues for paid members only.]
Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]
