![]() Sponsors must select at least 2 partners, including the FDA. Sponsors can select the number of partners included in a Project Orbis submission. The FDA then sends a proposal to the project partners to confirm their: Projects selected for Project Orbis have high-impact and clinically significant applications. sponsor can propose an application for Project Orbis. The FDA coordinates the selection of applications for Project Orbis.Įither the FDA or the U.S. Selection of submissions into Project Orbis conform to Health Canada submission requirements. ![]() Project Orbis Partners refer initial queries they receive to the FDA.Īs with any submission to Health Canada, a marketing submission identified as a Project Orbis collaboration should: Sponsors need to address the FDA with their initial inquiries about submission to Project Orbis.
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