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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Synchrocast: Understanding Brexit and its Impact on Patients

Synchrogenix's Darshan Kulkarni, Vice President, Regulatory Strategy and Policy, and Nirpal Virdee, Director, Client Services and Technology, talk about Brexit and its impact on patients. Listen in (or read the transcript) to learn more about Brexit, including the reasons behind the binary public referendum put to the United Kingdom's citizens back in 2016, and the outcome of the voting results. A ...

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Impact of the Government Shutdown on the FDA

The December 22, 2018 partial shutdown of the United States government affected roughly 25% of federal agencies, including the Food and Drug Administration (FDA), which has furloughed about 40% of its overall workforce. The duration of the shutdown is uncertain. In light of this uncertainty, it is important to understand the impact of the government shutdown on the FDA. FDA is using social medi ...

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