Cerus Announces FDA Agreement on Modular PMA App Submission Process for INTERCEPT Platelets

Cerus Corporation CERS announced today that the U.S. Food and Drug Administration (FDA) has accepted its proposed modular Premarket Approval (PMA) application shell for review of the INTERCEPT Blood System for platelets. A PMA shell is an outline of the application process that defines the structure, content and timing of each module. FDA and the applicant need to agree on a shell prior to initiation of a modular PMA submission. A modular PMA review process is based on submission of a compilation of sections or "modules" at 90-day intervals that together become a complete PMA application. Under a modular approach, FDA is able to review each module separately, allowing the applicant to receive timely feedback and potentially resolve deficiencies earlier in the review process than would be expected with a traditional PMA application. Cerus currently has a PMA application with respect to its plasma system that is being submitted in four modules. The PMA application shell accepted by the FDA for the platelet system provides for three modular submissions, with the first module scheduled for submission at the end of September.