Cerus announces FDA agreement on modular PMA application shell

theflyonthewall.com

Cerus Corporation announced that the U.S. Food and Drug Administration has accepted its proposed modular Premarket Approval 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. 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. Cerus recently announced its intention to pursue a modular PMA submission for the INTERCEPT Blood System for platelets after dialogue with the FDA indicated that the company could proceed with an application based on the existing dossier of clinical and routine use data, along with a post-marketing study commitment, rather than being required to complete an additional Phase III clinical study.

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