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Risk, Reward and The Pharmaceutical Lifecycle
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Major changes are underway in the reporting and enforcement environment for drug safety, with new regulations now in place in the US and Europe that require sponsoring companies to provide timely, comprehensive and accurate information to authorities, virtually on demand. REMS, RMPs, RiskMAPS, the Sentinel Initiative and other FDA programs geared to identifying product safety risks before they emerge as public health challenges raise the bar on what the sponsors must do to comply.
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