Reference
Department of Health and Human Services. FDA LACKS COMPREHENSIVE DATA TO DETERMINE WHETHER RISK EVALUATION AND MITIGATION STRATEGIES IMPROVE DRUG SAFETY. Internet Document : [38 pages], 1 Feb 2013. Available from: URL: https://oig.hhs.gov/oei/reports/oei-04-11-00510.pdf
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REMS lack data, according to US Inspector General. Reactions Weekly 1441, 4 (2013). https://doi.org/10.1007/s40278-013-1606-3
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DOI: https://doi.org/10.1007/s40278-013-1606-3