IMAGING AGENT APPROVAL BASED ON BROAD USES RATHER THAN SPECIFIC DISEASES ENDORSED BY PANEL; INDUSTRY-PROPOSED POLICY ADOPTED AS WORKING TEMPLATE
This article was originally published in The Gray Sheet
Executive Summary
Medical imaging agents should be approved for broad indications that could cover multiple diseases -- such as functional assessment of an organ -- rather than for disease-specific indications, members of FDA's Medical Imaging Drugs Advisory Committee agreed at a Feb. 15 meeting in Silver Spring, Maryland.