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Format and content for post-market drug benefit-risk assessment in Canada.: H164-255/2019E-PDF

"The objective of this guidance document is to assist Market Authorization Holders (MAHs) in developing a post-market benefit-risk assessment for a marketed drug when requested"--Objective, page 1.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.865274&sl=0

Publication information
Department/Agency
  • Canada. Health Canada.
TitleFormat and content for post-market drug benefit-risk assessment in Canada.
Publication typeMonograph
Language[English]
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Format et contenu des évaluations des avantages et des risques après la mise en marché au Canada.
  • "Guidance document."
  • Issued also in HTML format.
  • Includes references.
Publishing information
  • Ottawa : Health Canada, 2019.
  • ©2019
Description1 online resource (iii, 15 pages)
ISBN9780660287041
Catalogue number
  • H164-255/2019E-PDF
Departmental catalogue numberPub.: 180752
Subject terms
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