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FDA In Brief

This article was originally published in The Gray Sheet

Executive Summary

Clinical literature guidance: FDA is considering a collaboration with the National Institutes of Health and the Centers for Medicare & Medicaid Services on a guidance aimed at the use of literature to support claims. The device center and industry had been working on a genetic testing guidance addressing the use of literature in lieu of prospective trials (1"The Gray Sheet" Sept. 3, 2001, p. 8). That effort is currently "stalled," according to CDRH Division of Clinical Laboratory Devices Director Steven Gutman, who notes, however, that it could be revived via HHS intra-departmental collaboration. "NIH is interested in looking at use of clinical literature, and CMS is interested in looking at clinical literature. We are being instructed by [HHS Secretary] Tommy Thompson to behave as one department and try and actually be consistent across agencies," the DCLD director reports at the Association of Medical Diagnostics Manufacturers annual meeting...
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