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Let’s Be Careful Out There, Says FDA

30 June 2008

Legal Times
When the people’s representatives talk, the Food and Drug Administration is bound to listen. Last year, Congress became concerned enough about the serious side effects of FDA approved drugs — think Vioxx and Avandia — to take action. Now the FDA has sweeping new power to require risk mitigation strategies for drugs heading to market or already approved. And the agency has not been shy about using that power.


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