Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU)-Reference-Cited by-同舟云学术

Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU)

Published:2017-02-03 Issue:2 Volume:17 Page:245-254
ISSN:1174-5886
Container-title:Drugs in R&D
language:en
Short-container-title:Drugs R D

Author:

Boudes Pol F.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology

Link

http://link.springer.com/content/pdf/10.1007/s40268-017-0175-y.pdf

Reference34 articles.

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2. Cohen RA, Brown RS. The US Food and Drug Administration’s Risk Evaluation and Mitigation Strategy program in practice: does it really inform patients and limit risks? Am J Kidney Dis. 2012;59:604–6.

3. Matthews ML. Class-wide REMS for extended-release and long-acting opioids: potential impact on pharmacies. J Am Pharm Assoc. 2013;53:e1–7.

4. Szefler SJ, Whelan GJ, Leung DY. “Black box” warning: wake-up call or overreaction? J Allergy Clin Immunol. 2006;117:26–9.

5. Friedman RA. Antidepressants’ black-box warning—10 years later. N Engl J Med. 2014;371:1666–8.

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