This Chapter provides an introduction and overview of the U.S. FDA REMS program and applicable regulatory aspects. Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.
CITATION STYLE
Loeser, K. K., McKoy, J. M., & Schumock, G. T. (2019). Anatomy of risk evaluation and mitigation strategies (REMS). In Cancer Treatment and Research (Vol. 171, pp. 93–105). Springer International Publishing. https://doi.org/10.1007/978-3-319-43896-2_7
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