FDA Grants Cerus’ INTERCEPT Blood System Expanded Label

The FDA has approved Cerus’ INTERCEPT Blood System for the treatment of platelets suspended in 100 percent plasma.

Previously approved by the FDA in December 2014 for treatment of platelets collected in a platelet additive solution, the expanded label improves compatibility with widely used platelet collection procedures.  

“The label claim expansion will be valuable for blood centers as they consider how to address the revised draft guidance document for bacterial safety standards just issued this week by the FDA, as well as the proposed revised standards set forth in the Code of Federal Regulations,” said William Greenman, president and CEO of  Cerus. — Anisa Jibrell