• Organization: U.S. Department of Health & Human Services
• Updated: 2013-09-26

Companies are required under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (as amended by the Food and Drug Administration Safety and Innovation Act) to notify FDA of a...

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• Organization: U.S. Department of Health & Human Services
• Updated: 2025-09-06

Background Oral anticoagulants like the coumarin derivatives are characterised by a particularly narrow therapeutic range. Any interfering co-medication can pose a challenge to...

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