Risk Minimization Guidance Trio Focus On All Aspects Of Drug Development
This article was originally published in The Tan Sheet
Executive Summary
Findings from actual use trials on OTC drugs may be helpful in reducing the risk of medication errors, FDA says in a final guidance on FDL-1Premarketing Risk Assessment
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Stakeholders' misperceptions about FDA's Risk Minimization Action Plans program have prompted the agency to consider how to provide clarity, including creating a Web site that will serve as a central source of risk-management plan information
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