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Regulatory Focus™ > News Articles > Post-FDAAA Changes in Drug Safety: Where Are We Today?

Post-FDAAA Changes in Drug Safety: Where Are We Today?

Posted 01 May 2009

Beginning in 2004, a perfect storm of highly publicized drug withdrawals for safety reasons, allegations of drug companies withholding safety information, and growing public mistrust in the ability of the Food and Drug Administration (FDA) to protect the public health led to intense focus on drug safety that culminated in significant regulatory reform via new legislation.

 

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