Cerus Corporation CERS announced today that it has submitted the
first of three modules for its Premarket Approval (PMA) application to the
U.S. Food and Drug Administration (FDA), for review of the INTERCEPT Blood
System for platelets.
The PMA application shell for the platelet system, accepted by the FDA in
April, provides for three modular submissions. This enables FDA to review each
module separately, and allows the applicant to receive timely feedback to
resolve possible deficiencies earlier in the review process when compared to a
traditional PMA application.
In addition to the PMA for platelets, as of August 30, 2013, Cerus submitted
to FDA the third of four modules for its modular PMA application for review of
the INTERCEPT Blood System for plasma.
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