ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

March 12, 2003

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

AGENDA

Day 1: Wednesday, March 12, 2003

8:30 Call to Order Art Kibbe, Ph.D., Chair

Conflict of Interest Kathleen Reedy, Exec. Sec.

8:35 Introduction to Meeting Helen Winkle, Acting Director OPS

8:55 Subcommittee Updates

PAT Tom Layloff, Ph.D.

Manufacturing Ajaz Hussain, Ph.D.

Joseph Famulare

Clinical Pharmacology Jurgen Venitz, M.D.

9:40 Future Subcommittees

Biopharmaceutics Ajaz Hussain, Ph.D.

Microbiology Peter Cooney, Ph.D.

Pharmacology/Toxicology Robert Osterberg, Ph.D.

10:25 Break

10:40 Topical Dermatological Yuan-yuan Chiu, Ph.D.

Drug Product Nomenclature

Guest Presenters:

Keith Marshall

Herb Carlin, D.Sc.

12:30 Lunch

1:30 Open Public Hearing

2:00 Topical Dermatological Bioequivalence - Ajaz Hussain, Ph.D.

Methods Development

Presenters:

Ajaz Hussain, Ph.D.

Jonathan Wilkin M.D.

Dena Hixon, M.D.

Dale Conner, PharmD

3:15 Break

3:30 Comparability Protocols Yuan-yuan Chiu, Ph.D.

Presenters:

Stephen Moore, Ph.D.

Nancy Sager

5:00 Adjourn