Health Canada PRCI Guiding Principles and Observations

Health Canada released guidance on March 12, 2019 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes to enable re-analyses of data, foster new research questions, and help Canadians to m ...

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Summary of Health Canada’s Public Release of Clinical Information Initiative

Health Canada released guidance on March 12, 2019 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes to enable re-analyses of data, foster new research questions, and help Canadians to m ...

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FDA Seeking Feedback on Drug Approval Transparency and Disclosure Efforts

By Kristin McDougall, Workstream Lead, Transparency & Disclosure Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s ...

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Clarifications Concerning Health Canada’s Draft Guidance on the Public Release of Clinical Information – Part III

Over the past two weeks we have shared our questions and clarifications concerning Health Canada's draft guidance on the Public Release of Clinical Information. Following is Part III, which represents the conclusion of this series. Please click here to read Part I. Please click here to read Part II. Clarifications Concerning Health Canada's Draft Guidance on the Public Release of Clinical Informa ...

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Clarifying Health Canada’s Public Release of Clinical Information Draft Guidance – Part II

Last week we shared Part I of our three-part series on the questions and clarifications we submitted to Health Canada regarding their draft guidance on the Public Release of Clinical Information. Many thanks to everyone who commented with their insight. Following is Part II. Please leave your comments below to keep the conversation going. Health Canada's Public Release of Clinical Information: Ou ...

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