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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...

पूर्ण विवरण

में बचाया:
ग्रंथसूची विवरण
में प्रकाशित:Front Pharmacol
मुख्य लेखकों: Leong Wai Yeen, James, Salek, Sam, Walker, Stuart
स्वरूप: Artigo
भाषा:Inglês
प्रकाशित: Frontiers Media S.A. 2014
विषय:
ऑनलाइन पहुंच: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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