Regulatory ApprovalThe review of CERS's CE Mark application for INTERCEPT RBC was completed without receiving approval, prompting the company to assess new strategies for regulatory submission.
Regulatory ChallengesThe review of CERS' CE Mark application for INTERCEPT RBC has been completed without granting approval.
Regulatory ReviewThe company's application for INTERCEPT RBC had previously been under review by the EU Competent Authority, CBG, and concluded that the data are insufficient to support the proposed classification of the impurity profile of the final product.