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Regul. Toxicol. Pharmacol. · Feb 2019
Assessment of the approved Risk Evaluation and Mitigation Strategy programs for New Drug Applications and Biologics Licensing Applications.
- Nina A Johnson and Ronny Priefer.
- Western New England University, Springfield, MA, 01119, United States.
- Regul. Toxicol. Pharmacol. 2019 Feb 1; 101: 53-56.
AbstractThe 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.Copyright © 2018 Elsevier Inc. All rights reserved.
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