Reference
US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access. Internet Document : 8 Nov 2017. Available from: URL: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584259.htm
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US FDA issues draft guidance on shared REMS for generics. Reactions Weekly 1679, 3 (2017). https://doi.org/10.1007/s40278-017-38728-y
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DOI: https://doi.org/10.1007/s40278-017-38728-y