Rapidly evolving safety risk management processes increasingly dictate drug approval and post-marketing surveillance 1.To meet FDA requirements of developing and implementing changes to risk-evaluation and mitigation strategies (REMS), and to streamline this complicated process, we have detailed a framework of key concepts, standards and submission procedures. Health and safety management system Framework. REMS supersedes RiskMAPs. liver function monitoring to mitigate risk of liver damage and pregnancy screening with a negative result to mitigate risk of severe birth defects), Seriousness of known or potential adverse events, Do not affect information in REMS materials regarding serious risk or safe use, and. 143 0 obj <>stream FDA, CDER, Office of Regulatory Policy. Examples of common ETASU include: Safety measures of a REMS are unique to a drug’s associated safety risks.

Retrieved from https://www.fda.gov/media/105565/download, 4 U. S. Food and Drug Administration. Retrieved from https://www.fda.gov/media/86199/download, 3 Lippmann, E. (2017).

Center for Drug Evaluation and Research. %%EOF (2016) Background Materials for REMS Standardization and Evaluation Public Meeting. The FDA can require a REMS at any time, pre- or post- approval, and a REMS can be required for a single drug, or for a class of drugs.

The safety of staff, students and visitors to our campuses and facilities is a key priority. Changes have a limited effect on actions that must be taken in order to comply with the REMS.

4. ŞyÛÀ¨[^êQÇ—¾�U:Ñ€8ğ?¨�8§Ÿ!çtúr‰Â²¢ô0£™eµÒÙ*r+# ˜Í@pÖJ »(i¡9 ;b:9CpÖLrù~ ¤ ZYPJ²¿™/‰$šÅ—>µ^‰ö„óÄó´Ár¸2•±$Z²¿åP˜E¿ËD¢² Orl“ќœLVÍl.rŠÿ‡o&�Q`òšqÖá…ƒMd@™�)pÁh+äÃ#Ê®>Tz¦¬-õ%Å(¦²¸ôıf¡m˜õoh€×~W°H/SßÃsh•Èàİ€×…ˆ [ ]”Üô2­�´KS¡°¡ËHMÈPY 4¢J€Nê[tiÃ[)\ºpÖ¼Y$—p@ ç)2š¥fYÃ��цYL ñuy³ØÀ�Y¤«ë°Ğó$m3&Që´È°ÂÏèòR]. Changes to a REMS are categorized as REMS revisions, minor REMS modifications and major REMS modifications, depending on the degree of potential effect on serious risk, safe use and the actions necessary to comply with the REMS4.

All rights reserved. endstream endobj 115 0 obj <>/Metadata 16 0 R/PageLayout/OneColumn/Pages 112 0 R/StructTreeRoot 27 0 R/Type/Catalog>> endobj 116 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 117 0 obj <>stream

Recently published FDA draft guidances direct sponsors through the development of a REMS assessment plan and the execution of REMS assessment surveys, but these tasks remain difficult and intimidating. White Paper: Understanding Adaptive Designs for Clinical Trials, Deborah Cole, Marketing Associate, Amarex Clinical Research, LLC, an NSF International company, Shide Badri, Safety and Pharmacovigilance Professional, 1 Balian, J. D., Wherry, J. C., Malhotra, R., & Perentesis, V. (2010).