Pilot Exercises

The intent of the pilot exercises is to test the content and suitability of the Summary Basis of Decision (SBD) templates for drugs and medical devices while serving as a useful consultation tool. The resultant pilot SBDs were written with input from the respective submission and application sponsors; results will not be precedent setting.

	Summary Basis of Decision (SBD) Immulite 2000 System - Diagnostic Products Corporation Date: 2004-10-12
	Summary Basis of Decision (SBD) Crestor - AstraZeneca Canada Inc. Date: 2004-05-13
	Summary Basis of Decision (SBD) Fabrazyme - Genzyme Canada Inc. Date: 2004-05-13