From a pharmaceutical regulatory perspective in the United States, the decade of the 1990s was primarily about user fees, accelerated approvals and fast-track drugs. There was an unusual confluence of Congress, patient groups, the Food and Drug Administration (FDA) and industry all focused on a more timely and efficient drug approval process. The first decade of the twenty-first century will focus on drug safety, in part a reaction to what occurred in the 1990s. Risk management plans, restricted access, product monitoring and accelerated withdrawals will be the focus of that same confluence of interests. While innovative solutions will be discussed and embraced, pharmacovigilance has been, and will remain, at the heart of drug safety. This chapter will describe the legal basis and requirements for pharmacovigilance in the United States with regard to drugs and biological products. The chapter will then review how the FDA enforces these requirements and the penalties for non-compliance. For purposes of this chapter, pharma-covigilance 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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