U. S. Postmarketing Pharmacovigilance Compliance in the Midst of Regulatory Uncertainty

摘要

In the United States, heightened concern about safe use of such marketed medical products as prescription and non-prescription drugs, biologies and medical devices has been manifest for the past several years. As a result, the methods by which the relative benefit/risk balance of medical products are assessed, monitored and acted upon have come under intense public, congressional and legal scrutiny. This attention is not unprecedented, but the sustained focus on the Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) has called into question the effectiveness of what traditionally has been one of the most trusted federal agencies in the United States.