Who prepares the SBDs?
Technical editors draft the SBDs directly from the Health Canada review reports, vetting all information for accuracy with the responsible review authority. • Will I understand the SBD? Who is the intended audience? SBDs are written for all Canadians interested in the reasons why Health Canada has taken product-specific decisions for drugs and medical devices. The documents are drafted in technical language and although an accompanying Readers’ Guide and background documentation is provided as support, the reader may wish to consult their health care provider or alternative source for clarification of some of the technical terminology. The SBD is intended to complement information written in lay terminology and directed to the general public including operator’s manuals (devices), package inserts and Section 3 of the Product Monograph: “Information for the Public” (drugs). • What is industry’s involvement in terms of the content of the SBDs? The development of the SBDs is independent o
