Regulatory Focus™ > News Articles > In Focus: Risk Management

Posted 01 November 2008

In Focus: Risk Management

Risk management has become a primary focus for regulators when making final decisions on approving products. Sponsors must consider postmarketing risk and file information with the regulatory agency comparing the risks of using the product to its benefits. In some cases, the risks will be best managed with a formalized risk management plan designed appropriately for the product and its observed safety profile.


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