FDA issues draft guidelines for drug-coated stent makers

The FDA on Wednesday unveiled draft guidelines that recommend that makers of drug-coated stents conduct large and long-term studies of their products before and after they seek approval. The guidance provides parameters for companies planning to secure approval for new products, including Xtent, and does not seem to affect devices already on the market from Boston Scientific Corp., Johnson & Johnson and Medtronic.

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Wall Street Journal (free content), The · San Diego Union-Tribune

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