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'Patient Experience Data' Section Added To US FDA Drug Reviews

 
• By Sue Sutter

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.

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.

Section 3001 of the 21st Century Cures Act, which was signed into law in December 2016, requires FDA to make public a brief statement regarding patient experience data reviewed as...

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