Pulmonary/Allergy Drugs Advisory Committee Meeting
Jan 17, 2002
Holiday Inn Gaithersburg
Flovent Diskus (NDA# 20-833/S-004) and Advair Diskus (NDA# 21-077/S-003) as long-term maintenance therapy in patients with Chronic Obstructive Pulmonary Disease (COPD).
8:00 Welcome Mark S. Dykewicz, M.D.
Conflict of Interest Statement Kimberly Topper
8:15 Welcome and Topic Introduction Robert Meyer, M.D.
8:30 GlaxoSmithKline Presentations
Introduction Dr. David Wheadon
Scientific & Clinical Rationale Dr. Malcolm Johnson
Clinician's Perspective Dr. James Donohue
Clinical Efficacy & Safety Dr. Tushar Shah
Conclusions and Q&A Dr. David Wheadon
10:15 Break
10:30 FDA Presentations
Flovent Diskus for COPD Dr. Charles Lee
Advair Diskus for COPD Dr. Lydia Gilbert-McClain
Summary and Issues for PADAC Dr. Mary Purucker
12:00 Lunch
1:00 Open Public Hearing
Sol Epstein, MD, FRCP, FACP
2:00 Discussion
3:00 Break
3:15 Questions
5:00 Adjourn