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.

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publications.gc.ca/pub?id=9.833169&sl=1

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