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Regulatory Focus™ > News Articles > Quality & Compliance: Communication Strategies for Risk Minimization

Quality & Compliance: Communication Strategies for Risk Minimization

Posted 01 December 2008

In the US, the Food and Drug Administration (FDA) approves pharmaceutical products based upon the results of adequate, wellcontrolled clinical studies demonstrating that each product is safe and effective for its proposed indication. Efficacy must be commensurate with safety for a product to receive marketing approval.

 

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