Cerus Corporation Announces FDA Agreement on Modular Premarket Approval Application (PMA) Submission Process for INTERCEPT Plasma
Published: Dec 13, 2012
CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: 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.