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Public release of clinical information in drug submissions and medical device applications / Health Products and Food Branch.H164-205/2017E-PDF

"This document introduces Health Canada’s initiative to publicly release clinical information concerning the safety and efficacy of drugs and safety and effectiveness of medical devices. It sets out the policy objectives, rationale and considerations for future regulations that would specify that certain clinical information contained in drug submissions or medical device applications would not be treated or cease to be confidential business information following a final regulatory decision and that would authorize the public release of that information"--Preface, p. 1.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.833169&sl=0

Publication information
Department/Agency
  • Canada. Health Canada.
  • Canada. Health Products and Food Branch.
TitlePublic release of clinical information in drug submissions and medical device applications / Health Products and Food Branch.
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • Issued also in French under title: Diffusion publique de renseignements cliniques dans les présentations de médicaments et les demandes d’homologation d’instruments médicaux.
  • Cover title.
  • "March 10, 2017."
Publishing information
  • Ottawa : Health Canada, 2017, c2016.
Description8 p.
ISBN978-0-660-07793-2
Catalogue number
  • H164-205/2017E-PDF
Departmental catalogue number160346
Subject terms
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