ONCOLOGIC DRUGS ADVISORY COMMITTEE
December 13, 2000
Slides
NDA 20-726/S-006, FEMARA (letrozole) TABLETS
(First-Line Breast Cancer Indication)
FDA
Introduction, John Johnson, MD, FDA ppt html
FDA Presentation, Martin Cohen, MD, FDA ppt html
NOVARTIS
Introduction, Mathias Hukkelhoven, PhD
Hormonal Therapy of Breast Cancer, Harold A Harvey, MD
Pharmacology of Letrozole, Ajay S Bhatnager, PhD
Clinical Program, Margaret Dugan, MD
NDA 21-240, Histamine Hydrochloride Injection
Sponsor Presentation, MAXIM Pharmaceuticals ppt html
FDA
FDA Review, Judy H Chian, MD ppt html
Areas of Major Statistical Concerns in the M01 Study, Rajeshwari Sridhara, PhD ppt html
Study MP-US-M01, Donna Griebel, MD ppt