IMAGING AGENT APPROVALS SHOULD BE BASED ON STRENGTH OF DATA PROVIDED TO PRACTITIONER, CORAR TELLS FDA CMTE.; WORKABLE POINTS DUE BY MID-JANUARY
This article was originally published in The Gray Sheet
Executive Summary
FDA should "recognize that the preapproval, development and review process" of medical imaging agents "should not be based on clinical utility or specific diseases, but on the performance of the procedure in providing information to the practitioner," according to a Council on Radionuclides and Radiopharmaceuticals statement prepared for an Oct. 26 meeting of the agency's Medical Imaging Drugs Advisory Committee in Silver Spring, Maryland.