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FDAnews Device Daily Bulletin
June 19, 2012 | Vol. 9 No. 120
Industry Seeks Broader Expansion of Health Canada SBD Initiative
Medical devicemakers, drug companies and some local government officials are urging Health Canada to expand its Summary Basis of Decision (SBD) initiative so product approval reports are published more quickly and on a wider range of products. According to stakeholders, the project’s second phase — set to get underway this summer following more stakeholder feedback — should include market authorization of a new device, drug or biologic; approval or rejection of a supplemental new drug submission, and withdrawal of a product which received a notice of compliance with conditions.
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