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Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents
The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovati...
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| Publicado no: | Front Pharmacol |
|---|---|
| Main Authors: | , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Frontiers Media S.A.
2014
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4255503/ https://ncbi.nlm.nih.gov/pubmed/25538620 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3389/fphar.2014.00269 |
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