Public release of clinical information in drug submissions and medical device applications: 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.
|Department/Agency||Health Canada. Health Products and Food Branch.|
|Title||Public release of clinical information in drug submissions and medical device applications|
|Other Language Editions||[French]|
|Electronic Document|| |
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|Note||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."|
|Number of Pages||8 p.|
|Departmental Catalogue Number||160346|
|Subject Terms||Drugs, Medical products, Freedom of information, Government policy|
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