Cerus Corporation CERS announced today that the U.S. Food and Drug
Administration (FDA) has accepted its proposed modular Premarket Approval
application (PMA) shell for review of the INTERCEPT Blood System for plasma. 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.
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 recently announced its intention to pursue a modular PMA submission
after dialogue with the FDA indicated that the company could proceed with
an application for multiple indications of plasma use, not just the thrombotic
thrombocytopenic purpura (TTP) indication for which Cerus received orphan drug
designation last year.
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