Blueprint For Evaluating And Mitigating Drug Risk

Law360, New York (October 21, 2009, 5:50 PM EDT) -- On Sept. 30, 2009, the U.S. Food and Drug Administration released a draft of its Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications.

Although the FDA refers to the guidance as a draft, the document offers insight into the agency's current thinking about risk management for certain drug and biological products.

Background

In recent years, there has been concern over a perceived lack of communication between the FDA and the pharmaceutical industry regarding safety-related...
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