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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.
| Original language | English (US) |
|---|---|
| Title of host publication | Cancer Treatment and Research |
| Publisher | Springer International Publishing |
| Pages | 93-105 |
| Number of pages | 13 |
| DOIs | |
| State | Published - Jan 1 2019 |
Publication series
| Name | Cancer Treatment and Research |
|---|---|
| Volume | 171 |
| ISSN (Print) | 0927-3042 |
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Keywords
- CDER
- Mitigation
- OPDP
- Oncology
- Pharmaceuticals
- Prescription drugs
- REMS
- Risk evaluation
- U.S. food and drug administration (FDA)
ASJC Scopus subject areas
- Oncology
- Cancer Research
Cite this
}
Anatomy of risk evaluation and mitigation strategies (REMS). / Loeser, Kari K.; McKoy, June M; Schumock, Glen T.
Cancer Treatment and Research. Springer International Publishing, 2019. p. 93-105 (Cancer Treatment and Research; Vol. 171).Research output: Chapter in Book/Report/Conference proceeding › Chapter
TY - CHAP
T1 - Anatomy of risk evaluation and mitigation strategies (REMS)
AU - Loeser, Kari K.
AU - McKoy, June M
AU - Schumock, Glen T.
PY - 2019/1/1
Y1 - 2019/1/1
N2 - 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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.
AB - 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 Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.
KW - CDER
KW - Mitigation
KW - OPDP
KW - Oncology
KW - Pharmaceuticals
KW - Prescription drugs
KW - REMS
KW - Risk evaluation
KW - U.S. food and drug administration (FDA)
UR - http://www.scopus.com/inward/record.url?scp=85058945283&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85058945283&partnerID=8YFLogxK
U2 - 10.1007/978-3-319-43896-2_7
DO - 10.1007/978-3-319-43896-2_7
M3 - Chapter
T3 - Cancer Treatment and Research
SP - 93
EP - 105
BT - Cancer Treatment and Research
PB - Springer International Publishing
ER -