Endocrinologic and Metabolic Drugs Advisory
Committee
Slides
The committee will discuss new drug application (NDA)
21-868,
proposed trade name Exubera (insulin recombinant
deoxyribonucleic acid (rDNA) origin powder for oral inhalation),
1 milligram
(mg) and 3 mg powder for inhalation, Pfizer, Inc., for the treatment of adult
patients with diabetes mellitus
Pfizer Global Research and
Development: Presentation
Introduction Neville
Jackson, M.D.
Full Development Team Leader, EXUBERA
Pfizer Global Research and Development
Overview of Clinical Program Anne
Cropp, Pharm.D.
Global Clinical Leader, EXUBERA
Pfizer Global Research and Development
Medical Needs William
Cefalu, M.D.
Professor
and Chief, Department of Nutrition and Chronic Diseases
Pennington Biomedical
Benefit and Managing the Risk Neville
Jackson, M.D.
Pfizer
Global Research and Development
ClinPharm
Backup Slides [HTML] [PPT]
Efficacy
Backup Slides [HTML] [PPT]
Non-Clinical
Backup Slides [HTML] [PPT]
Pulmonary
Safety Backup Slides [HTML] [PPT]
Risk
Management Backup Slides [HTML] [PPT]
FDA Review Division Presentation:
Clinical
Efficacy and Karen M. Mahoney, M.D.
Non-Pulmonary Safety Review Medical
Officer
FDA/CDER
Division Metabolic and Endocrine Drug
Products
Statistical
Review and Evaluation Joy D. Mele, M.S.
Statistician
FDA/CDER
Office of Pharmacoepidemiology and
Statistical Science
Clinical
Pharmacology and Sayed (Sam) Al Habet, R.Ph., Ph.D.
Biopharmaceutics
Review Senior
Clinical Pharmacologist/Reviewer
FDA/CDER
Office of Clinical Pharmacology and Biopharmaceutics
Clinical Pulmonary Safety Sally
Seymour, M.D.
Medical
Officer
FDA/CDER
Division of Pulmonary and Allergy Drug Products
Questions