Draft US guidances issued to assess REMS programmes

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e.g. drug utilisation data, postmarketing adverse event data, epidemiological data, etc.

Gottlieb S. FDA statement from Commissioner Scott Gottlieb, M.D. announcing efforts to improve the quality of the information used to assess the effectiveness of REMS programs in supporting the safe use of medications. Internet Document : 24 Jan 2019. Available from: URL: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629759.htm

Draft US guidances issued to assess REMS programmes. Reactions Weekly 1739, 3 (2019). https://doi.org/10.1007/s40278-019-57643-9

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