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Assuring Safety of Inherently Unsafe Medications: the FDA Risk Evaluation and Mitigation Strategies
The decision to approve a drug for clinical use is based on an understanding of its benefits versus the risks. Although efficacy is generally understood at the time of submission to the FDA for approval, the risks are more difficult to assess. Both PubMed (from 2000 to 2012) and the FDA website (www...
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| Autori principali: | , , |
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| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
Springer US
2014
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| Soggetti: | |
| Accesso online: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4057549/ https://ncbi.nlm.nih.gov/pubmed/24414251 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s13181-013-0374-z |
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