US-based biomedical products company Cerus has submitted the first of three modules for its premarket approval (PMA) application to the US Food and Drug Administration (FDA) for review of the Intercept blood system for platelets.
In April, the FDA accepted the system’s PMA application shell, which outlines the structure, content and timing of each PMA module with three modular submissions.
Under a modular approach, the FDA reviews each module separately and provides the applicant with timely feedback.
In addition to the PMA for platelets, as of 30 August, Cerus submitted to FDA the third of four modules for its modular PMA application for review of the Intercept blood system for plasma.
Cerus senior vice-president of regulatory affairs, quality and clinical Carol Moore said the company is on-target in meeting predicted timelines with respect to our PMA submissions.
"The second and third modules for platelets are scheduled for submission at the end of December 2013 and March 2014, respectively, and the last plasma module is scheduled for November 2013," Moore said.
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The company’s Intercept blood system has demonstrated a significant advancement in blood safety, while simultaneously providing protection from a wide variety of viruses, bacteria and parasites.
In addition, the system is capable of inactivating the established threats such as hepatitis B and C, HIV, West Nile virus and bacteria, as well as emerging pathogens such as influenza, malaria and dengue.
The company currently markets and commercialises the Intercept blood system for both platelets and plasma in Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions worldwide.
Cerus is currently seeking regulatory approval of the Intercept blood system for plasma and platelets in the US while the Intercept red blood cell system is in clinical development.