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Drugs and Health Products
Templates - Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies
In order to help expedite the review process, manufacturers or sponsors are expected to summarize drug submission data related to quality, or safety and efficacy, using the following WordPerfect® or MS Word templates, as appropriate, with drug submissions filed to the Biologics and Genetic Therapies Directorate.
In this topic:
Additional Resources:
Reconsideration of Final Decisions - Request for reconsideration
