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Canada To Disclose Why It Says No To Certain High-Risk Devices, Drugs

This article was originally published in Clinica

Executive Summary

As part of an ongoing transparency initiative, Health Canada has decided to make public the rationale behind its decision to reject marketing authorization applications for highest-risk medical devices, new drug submissions and supplemental drug submissions for new indications that are submitted for review by sponsors on or after May 1, 2016. Health Canada is already publishing its rationale for all positive decisions issued after April 1, 2015 in relation to these categories of devices and drugs. The rationale is published in the form regulatory decision summaries (RDS), which were introduced last year when phase I of the transparency initiative was launched.






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