role in assuring the safety and efficacy of prescription drugs now and in the future. Also, PDUFA reauthorization is just months away, and major legislation addressing drug regulation has been prepared and considered.15 These circumstances make this a golden moment of opportunity to improve fundamentally the way FDA regulation considers and responds to the evolving understanding of risks and benefits of drugs, and the way all stakeholders in the drug safety system perceive, study, and communicate about those risks and benefits. As described in Chapter 1, there have been many commissions and reports addressing issues similar to those contained in this report. It is the committee’s fervent hope that Congress, FDA, and the other stakeholders will seize the gathering momentum to invigorate the drug safety system. The agency’s credibility and its ability to protect and promote optimally the health of the American people cannot wait another year or another decade.


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The Enhancing Drug Safety and Innovation Act of 2006,

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