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Using Compliance Data for Strategic Advantage: Pharmacovigilance and Drug DevelopmentPart of an array of steadily growing pressures that face the industry, compliance requirements continue to increase in importance in pharmaceutical operations. Regulatory oversight and enforcement actions on a variety of compliance issues, including conflicts of interest, rising product prices, product safety, distributor agreements, and direct-to-consumer advertising are increasing, and this trend shows little sign of abating. At the same time, concerns about drug safety are driving rigorous regulatory scrutiny, especially during the approval process, as recent news reports indicate. Compounding these challenges, the industry is also dealing with pipeline issues; although R&D has increased, the number of new products submitted to the FDA has been dropping since the late 1990s.
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