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FDA’s Drug Safety Office Reorganizing To Accommodate Influx Of PDUFA Staff

Executive Summary

FDA's Office of Surveillance and Epidemiology is again undergoing changes as the agency continues to strengthen its drug safety operations. OSE is reorganizing prior to increasing staff by 50 percent to undertake new regulatory authorities

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FDA's drug review and drug safety offices have set aside their differences and laid out an agreement that more equally divides regulatory authority on issues related to drug safety

FDA Drug Review, Surveillance Offices Agree To Share Safety Authority

FDA's drug review and drug safety offices have set aside their differences and laid out an agreement that more equally divides regulatory authority on issues related to drug safety

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