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BioPharmaceutical United States Post Market Regulation & Studies

FDA Sentinel Transition Will Involve Expanding Rx Safety Data Sources

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Executive Summary

Moving Mini-Sentinel pilot program to a fully operational and sustainable Sentinel postmarket safety surveillance system will take place over next year, CDER Director Woodcock says.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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