The benefits and risks associated with pharmaceutical agents and medical devices have received increasing attention from the medical community, the public, and government agencies. Serious concerns about US Food and Drug Administration (FDA) capabilities and oversight for ensuring accurate determination of safety and efficacy, appropriate mechanisms and decisions regarding drug and device approval, and effective postmarketing surveillance have prompted investigations by the Institute of Medicine1 and by an FDA blue ribbon commission.2 Major legislation3 has been enacted to improve the agency's ability to fulfill the daunting responsibility of ensuring that pharmaceutical products and medical devices approved for marketing are safe.4
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