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.
Title Format and content for post-market drug benefit-risk assessment in Canada.
Publication type Monograph
Language [English]
Format Electronic
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
Description 1 online resource (iii, 15 pages)
ISBN 9780660287041
Catalogue number
  • H164-255/2019E-PDF
Departmental catalogue number Pub.: 180752
Subject terms Drugs
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