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FDAnews Drug Daily Bulletin
June 22, 2012 | Vol. 9 No. 123
Drugmakers Press Broader Expansion of Health Canada’s SBD Initiative
Drug and medical device 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 SBD reports of market authorization of a new drug, biologic or medical device; 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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