ORALLY INHALED AND NASAL DRUG PRODUCTS SUBCOMMITTEE

OF THE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

July 17, 2001

Tentative AGENDA

8:30 Call to order/Chairmanís Remarks Vincent H.L. Lee, Ph.D.

8:40 Introduction and Objectives Helen Winkle

Background

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.

Study Designs

10:15 Clinical study options for locally acting suspension formulation

nasal sprays and nasal aerosols Robert J. Meyer, M.D.

10:45 Break

11:00 Subcommittee Discussion

11:30 Open Public Hearing

12:30 Lunch

1:30 Subcommittee Discussion

2:45 Break

3:00 Subcommittee Discussion

5:30 Adjourn

7/9/01