Johnson Nina A, Priefer Ronny
Western New England University, Springfield, MA, 01119, United States.
Western New England University, Springfield, MA, 01119, United States.
Regul Toxicol Pharmacol. 2019 Feb;101:53-56. doi: 10.1016/j.yrtph.2018.10.014. Epub 2018 Oct 26.
The Food and Drug Amendments Act of 2007, (FDAAA), granted the United States Food and Drug Administration to require drug manufacturers to develop a Risk Evaluation and Mitigation Strategy, (REMS). Implementation of the FDAAA required drug manufacturers to utilize risk minimization strategies beyond routine labeling for benefit-risk profiles of prescription drugs. The first full year of FDAAA implementation, 2008, through 2016, was reviewed to assess presence of differences in REMS requirements in Center for Drug Evaluation and Research (CDER) New Drug Applications, (NDAs), and Biologics License Applications, (BLAs). The risks present in the current unreleased approved REMS were reviewed to determine any difference in FDA requirements for safety risks identified in the NDA and BLA REMS programs.
2007年《食品药品管理修正案》（FDAAA）授权美国食品药品管理局要求药品制造商制定风险评估与缓解策略（REMS）。FDAAA的实施要求药品制造商在常规标签之外采用风险最小化策略，以应对处方药的获益-风险情况。对2008年至2016年FDAAA实施的首个完整年度进行了审查，以评估药品评价和研究中心（CDER）的新药申请（NDAs）及生物制品许可申请（BLAs）中REMS要求的差异情况。对当前未发布的已批准REMS中存在的风险进行了审查，以确定FDA在NDA和BLA的REMS计划中对已识别安全风险的要求是否存在差异。
