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Updated: Feb 1, 2026

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
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Anatomy of Risk Evaluation and Mitigation Strategies (REMS)
Kari K Loeser1, June M McKoy2, Glen T Schumock3
1Legal & Compliance Department, Relypsa, Redwood City, CA, USA. kkloeser@gmail.com.
Abstract:
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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.
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