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FDA Commissioner Scott Gottlieb said the agency’s least burdensome approach policy approach is “a hallmark of our efforts to help innovators generate… Read More
Heath Canada intends to begin piloting the use of its Regulatory Enrollment Process through the Common Electronic Submission Gateway for medical device applications by this summer. Read More
The SynchroMed II application provides visual tools, such as flex dosing graphics, and guided workflows, with the goal of simplifying treatment management. Read More
A new IVD application for priority review status should include a justification for how early market availability in the country will result in improved health. Read More