Centocor serum tumor marker reclassification petition to go before FDA panel.
This article was originally published in The Gray Sheet
Executive Summary
SERUM TUMOR MARKER DOWNCLASSIFICATION PETITION TO BE REVIEWED BY PANEL, FDA staffers say. The agency is planning a fall meeting of its Immunology Devices Panel to address a citizens petition recently submitted by Centocor seeking reclassification of serum tumor markers from their current Class III status to Class II. FDA had been planning a public workshop for this summer on the regulatory status of the devices; however, scheduling problems with possible participants and the submission of the Centocor petition convinced the agency that a panel meeting would be a more appropriate forum for discussion of the issue.
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