Canada & United States — Food and Drug Administration
13 shared events · Importance 14 · Last updated Jul 02, 2026
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Regulatory
Canada: Spectral Medical signed an exclusive distribution agreement for PMX in Canada.
United States — Food and Drug Administration: The United States — Food and Drug Administration completed its filing review and formally filed Spectral Medical's Premarket Approval application for PMX, initiating the substantive review phase.
Jun 25, 2026 · 6 articles
Business
Canada: The acquired manufacturing platform supplies into multiple global markets including Canada, indicating its international reach.
United States — Food and Drug Administration: The acquired facilities have completed multiple United States — Food and Drug Administration inspections with clean results, indicating compliance with regulatory standards.
Jul 02, 2026 · 7 articles
International
Canada: Remplir is cleared for use and sale in Canada.
United States — Food and Drug Administration: The United States — Food and Drug Administration cleared Remplir for use in April 2025, which is a significant regulatory milestone for the device.
Jun 29, 2026 · 6 articles
Tech
Canada: Canada is the location where the 6th World Congress of Cutaneous Lymphomas meeting took place, where the PROSPER study data was presented.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) is the regulatory body in the U.S. to which suspected adverse reactions to POTELIGEO are encouraged to be reported.
Jun 29, 2026 · 7 articles
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