Health Affairs, 24, no. 4 (2005): 927 doi: 10.1377/hlthaff.24.4.927 © 2005 by Project HOPE	New Online   How Would Obama, McCain Cover The Uninsured?   Debating Cost Of Uninsured   Try Medicare-For-All   HA Blog Top 10

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FDA Under Scrutiny

PROLOGUE

How To Get The Data? Scrutiny Of Postmarketing Surveillance At The FDA

How do we prove that our drugs and therapeutic devices are safe? This has been the core mission of the U.S. Food and Drug Administration (FDA) since its founding in the first decade of the twentieth century. Recent events in the wake of Merck’s withdrawal of Vioxx and the return of silicone breast implants have subjected the FDA’s approval procedures and postmarketing surveillance to intense scrutiny. Congress, newspaper and journal articles, bloggers, and even stockholders have questioned whether the FDA is capable of upholding its mission. Do we need to strengthen the postmarketing surveillance group within the FDA? Do we . . . [Full Text of this Article]

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