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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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| Vydáno v: | Front Pharmacol |
|---|---|
| Hlavní autoři: | , , |
| Médium: | Artigo |
| Jazyk: | Inglês |
| Vydáno: |
Frontiers Media S.A.
2014
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| Témata: | |
| On-line přístup: | 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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