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Will FDA’s New Requirements For Drug-Eluting Stents Impact Innovation?

This article was originally published in The Gray Sheet

Executive Summary

Shifting regulatory requirements are compelling medical device companies, both big and small, to be more prudent with their R&D dollars

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Industry Presents Wish List For DES Guidance At CRT Conference

FDA's forthcoming guidance on drug-eluting stents should provide specific requirements for preclinical, clinical and postmarket studies to help manufacturers get safe products to market quickly, according to stakeholders

Industry Presents Wish List For DES Guidance At CRT Conference

FDA's forthcoming guidance on drug-eluting stents should provide specific requirements for preclinical, clinical and postmarket studies to help manufacturers get safe products to market quickly, according to stakeholders

TCT Conference In Brief

DES draft guidance in signature stage: FDA hopes to release a draft of its new drug-eluting stent guidance document within the next few weeks, CDRH Director Dan Schultz says Oct. 23 at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C. The highly anticipated two-part document is over 100 pages long, covering chemistry manufacturing controls and safety evaluation of the eluting drug, animal and biocompatibility studies, non-clinical bench testing, and new recommended designs for pre- and postmarket clinical studies (1"The Gray Sheet" March 12, 2007, p. 3). FDA will host a public workshop to solicit feedback once the draft is released

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