FDA Briefing Package

NDA 21-628 Certican® (everolimus)

FDA

Division of Special Pathogen and Transplant Products

Cardiovascular and Renal Drugs Advisory Committee Meeting

November 16, 2005

 

Table of Contents

 

  1. Draft Discussion Points for Consideration

 

2.  FDA Briefing Package Introduction

 

3.  Medical Officer Review – Heart Transplantation

 

4.  Medical Officer Review – Renal Safety

 

5.  Statistical Review [Original Submission]

 

6.  Statistical Review [Resubmission]

 

7.  Clinical Pharmacology – Executive Summary

 

8.  Clinical Pharmacology [Original Review]

 

9.  Clinical Pharmacology [Resubmission Review]

 

10. Clinical Pharmacology [Amendment]

 

11. Clinical Pharmacology – Exposure Response Relationships

 

12. Publications – Bibliography