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.

Additional Resources:

Reconsideration of Final Decisions - Request for reconsideration

Page details

Date modified: