Regulatory Aspects of Optical Methods and Exogenous Targets for Cancer Detection

This report is the result of a one-day meeting held on May 4, 2016 with officials from the National Cancer Institute, the FDA, members of the American Society of Image-Guided Surgery, and members of the World Molecular Imaging Society, which discussed consensus methods for FDA-directed human testing and approval of investigational optical imaging devices as well as contrast agents for surgical applications. The goal of this workshop was to discuss FDA approval requirements and the expectations for approval of these novel drugs and devices, packaged separately or in combination, within the context of optical surgical navigation. In addition, the workshop acted to provide clarity to the research community on data collection and trial design. Reported here are the specific discussion items and recommendations from this critical and timely meeting. Cancer Res; 77(9); 2197–206. ©2017 AACR.

Source: Cancer Research - April 30, 2017 Category: Cancer & Oncology Authors: Willemieke S. Tummers, Jason M. Warram, Kiranya E. Tipirneni, John Fengler, Paula Jacobs, Lalitha Shankar, Lori Henderson, Betsy Ballard, Brian W. Pogue, Jamey P. Weichert, Michael Bouvet, Jonathan Sorger, Christopher H. Contag, John V. Frangioni, Michael Tags: Meeting Report Source Type: research