ORALLY INHALED AND NASAL DRUG PRODUCTS SUBCOMMITTEE
OF THE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
July 17, 2001
8:30 Call to order/Chairmanís Remarks Vincent H.L. Lee, Ph.D.
8:40 Introduction and Objectives Helen Winkle
8:50 Bioequivalence considerations
for locally acting nasal drugs Dale P. Conner, Pharm.D.
9:15 The June 1999 Draft Nasal BA/BE Guidance Wallace P. Adams, Ph.D.
9:45 Difficulties with showing a dose-responsewith locally acting nasal sprays and aerosols
for allergic rhinitis Badrul Chowdhury, M.D.
10:15 Clinical study options for locally acting suspension formulation
nasal sprays and nasal aerosols Robert J. Meyer, M.D.
11:00 Subcommittee Discussion
11:30 Open Public Hearing
1:30 Subcommittee Discussion
3:00 Subcommittee Discussion