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FDLI Annual Conference In Brief

This article was originally published in The Gray Sheet

Executive Summary

DES deemed model for FDA/CMS collaboration: CMS Administrator Mark McClellan, MD/PhD, is "very interested" in creating a faster pathway to market for promising new devices and drugs by better coordinating the approval and reimbursement processes at FDA and CMS. "A great model going forward for important new technologies" is mirroring "the work that we did jointly on drug-eluting stents where - with the manufacturers' support - our FDA staff was able to share the information we were using for the product approval decisions with CMS so that when FDA made its approval decision, the coverage codes and coverage for that treatment came right away," he explained at the Food & Drug Law Institute Annual Meeting April 15 in Washington, D.C...
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