Summary Basis of Decision: Phase 1
Summary Basis of Decision (SBD) documents are aimed at all Canadians interested in the basis for Health Canada's product-specific decisions for drugs and medical devices. They are accompanied by Reader's guides and background documentation.
In this first phase, SBDs will be published for New Drug Submissions for New Active Substances and a subset of Class IV medical device applications authorized after January 1, 2005.
SBDs are intended to reflect the information available to the regulator at the time of authorization. They are not intended to be a vehicle for communicating all important up-to-date safety information on a product. Such information is communicated through the issuance of Advisories, Warnings and Recalls.
A Notice of Decision (ND) is a one-page summary outlining the authorization received and general information related to the drug or medical device. NDs will be posted independently approximately two weeks after product authorization. This document was created in response to stakeholder feedback and will provide timely access to general information related to the product. When the SBD is published, the ND will be incorporated into the SBD as Section 2.
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