The US FDA's recent approval of Genentech Inc.'s hemophilia A treatment Hemlibra (emicizumab-kxwh) shows how the agency is implementing a new transparency requirement related to patient experience data for drug and biologic applications.
'Patient Experience Data' Section Added To US FDA Drug Reviews
Genentech's hemophilia A treatment Hemlibra is among first products to include new dedicated section on patient experience data in its review documents as FDA begins implementing 21st Century Cures Act provision.