FDA OFFICE OF POST-MARKETING DRUG RISK ASSESSMENT WILL TRACK PHASE IV SAFETY STUDIES; TWO DRUG RISK DIVISIONS WILL DIVIDE NME WORKLOAD, TRACK DRUGS IN TEAMS
Executive Summary
FDA will track Phase IV safety studies through a new Office of Post-marketing Drug Risk Assessment, Center for Drug Evaluation & Research Deputy Director for Review Management Murray Lumpkin said in a memo to FDA employees Dec. 23.
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