FDA Briefing Package
NDA 21-628 Certican® (everolimus)
FDA
Division of Special Pathogen and Transplant Products
Cardiovascular and Renal Drugs Advisory Committee Meeting
Table of Contents
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