FDA Previews New Drug-Eluting-Stent Guidance At CRT Meeting In D.C.
This article was originally published in The Gray Sheet
Executive Summary
FDA's upcoming drug-eluting-stent guidance will emphasize long-term safety and shift the focus of trials from surrogate to clinical endpoints
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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DES draft guidance in signature stage: FDA hopes to release a draft of its new drug-eluting stent guidance document within the next few weeks, CDRH Director Dan Schultz says Oct.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
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DES draft guidance in signature stage: FDA hopes to release a draft of its new drug-eluting stent guidance document within the next few weeks, CDRH Director Dan Schultz says Oct.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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