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Volume 358:1773-1777 April 24, 2008 Number 17
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Trying Times at the FDA — The Challenge of Ensuring the Safety of Imported Pharmaceuticals
Stuart O. Schweitzer, Ph.D.

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In recent years, the Food and Drug Administration (FDA) has faced three serious challenges to its ability to ensure the safety of the country's medical devices and drugs. The first arose when the widely marketed drug Vioxx (rofecoxib) was shown to be dangerous enough for its manufacturer to withdraw it from the market. Previously, consumers and most physicians had assumed that the FDA's drug-approval process, though not legally guaranteeing a product's safety, could be trusted to assure the public of its relative safety. The challenge to physicians, who were forced to confront their prescribing habits, was no less than that . . . [Full Text of this Article]


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Dr. Schweitzer is a professor in the Department of Health Services at the UCLA School of Public Health, Los Angeles.



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