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- Title
Erythropoietins locked into risk management program.
- Authors
Ratner, Mark
- Abstract
The article reports on the agreement reached by the U.S. Food and Drug Administration (FDA) with the manufacturers of erythropoietin stimulating agents (ESA) in 2010 to reduce the risks linked with these drugs. As disclosed, drug makers will function under a risk evaluation and mitigation strategy (REMS) effective March. According to the article, the REMS program requires healthcare providers who prescribe the drugs for cancer patients to register with the drug manufacturers and enroll in a training program on their use.
- Subjects
UNITED States; CONTRACTS; UNITED States. Food &; Drug Administration; ERYTHROPOIETIN; MEDICATION safety; PHARMACEUTICAL industry; RISK assessment; THERAPEUTICS
- Publication
Nature Biotechnology, 2010, Vol 28, Issue 4, p303
- ISSN
1087-0156
- Publication type
Article
- DOI
10.1038/nbt0410-303a