Monday, December 10, 2018

Cerus: American Red Cross receives BLA approval for INTERCEPT platelets


Cerus Corporation announced that the American Red Cross has received approval by the U.S. Food and Drug Administration for their first biologics license application for interstate distribution of platelets that have been pathogen-reduced with INTERCEPT Blood Systems. The Biologics License Application is a common procedure for blood centers to request permission by FDA to introduce a biologic product into interstate commerce. Until a blood center obtains a BLA, they are restricted to distributing INTERCEPT-treated products to hospitals within the state in which they are produced. While some blood centers may distribute primarily in state, many U.S. blood centers have extensive interstate distribution.
https://thefly.com/landingPageNews.php?id=2834507

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.