Legal Basis - United States

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Chapter: Pharmacovigilance: Legal Basis - United States

During the decade of the 1990s, pharmaceutical regulation in the United States was dominated by a deter-mined focus to develop a more timely and efficient drug approval process.


Legal Basis - United States

INTRODUCTION

During the decade of the 1990s, pharmaceutical regulation in the United States was dominated by a deter-mined focus to develop a more timely and efficient drug approval process. This emphasis was advanced by an usual confluence of interest by Congress, patient groups and the Food and Drug Administration (FDA).

By contrast, the initial years of the twenty-first century have focused on drug safety, perhaps in part a reaction to what occurred in the 1990s. Risk-management plans, product monitoring, post-marketing surveillance and accelerated withdrawals have become the new focus of that same confluence of interests. Although innovative solutions are being discussed, and some will be embraced, pharmacovig-ilance has been, and will remain, at the heart of drug safety.

This chapter will describe the legal basis and require-ments for pharmacovigilance in the United States with regard to drugs and biological products. This chapter will then review how the FDA enforces these requirements and the penalties for non-compliance. For purposes of this chapter, pharmacovigilance means the collection, analysis and submission to the FDA of adverse experiences and other safety information related to drugs and biological products.

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