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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Bibliographic Details
Main Authors: James eLeong Wai Yeen (Author), Sam eSalek (Author), Stuart eWalker (Author)
Format: Book
Published: Frontiers Media S.A., 2014-12-01T00:00:00Z.
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3rd Floor Main Library

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Call Number: A1234.567
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