Food and Drug Administration

Center for Drug Evaluation and Research

 

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE (ACPS)

October 19-20, 2004

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

TENTATIVE AGENDA

 

Day 1: Tuesday, October 19, 2004

 

8:30 Call to Order Arthur Kibbe, Ph.D.

Chair, ACPS

 

Conflict of Interest Statement Hilda Scharen, M.S.

Executive Secretary, ACPS

 

Introduction to Meeting Helen Winkle

OPS Update Director, Office of Pharmaceutical Science

Pharmaceutical Quality for the 21st Century (OPS), CDER, FDA

 

 

Subcommittee Reports

Manufacturing Subcommittee Judy Boehlert, Ph.D.

Chair, Manufacturing Subcommittee

 

Parametric Tolerance Interval Test

for Dose Content Uniformity

 

Update on the FDA/IPAC-RS Working Group

 

Committee Discussions and Recommendations

 

10:15 Break

The Critical Path Initiative Challenges and Opportunities

 

Research Opportunities and Strategic Direction

12:00 Lunch

 

1:00 Open Public Hearing

 

Critical Path Initiative (Continued)

 

3:15 Break

 

Committee Discussion and Recommendations

 

 

5:00 Adjourn


Food and Drug Administration

Center for Drug Evaluation and Research

 

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE (ACPS)

October 19-20, 2004

CDER Advisory Committee Conference Room

5630 Fishers Lane

Rockville, MD

 

TENTATIVE AGENDA

 

Day 2: Wednesday, October 20, 2004

 

8:30 Call to Order Arthur Kibbe, Ph.D.

Chair, ACPS

 

Conflict of Interest Statement Hilda Scharen, M.S.

Executive Secretary, ACPS

 

The "Desired State" of Science- and Ajaz Hussain, Ph.D.

Risk-based Regulatory Policies

 

(1) Science in Regulation -- Visionary Overview Arthur Kibbe, Ph.D.

(2) Plans and Activities to Move OPS Forward

(3) OPS Policy Development

(4) GPhA Perspective

(5) PhRMA Perspective

 

Committee Discussion and Recommendations

 

12:00 Lunch

 

1:00 Open Public Hearing

 

 

2:00 Pharmaceutical Equivalence and Bioequivalence of Generic Drugs

(1) The Concept and Criteria of BioINequivalence

(2) Bioequivalence Testing for Locally Acting Gastrointestinal Drugs

 

 

 

2:45 Break

 

 

Committee Discussion and Recommendations

 

 

 

4:30 Conclusion and Summary Remarks Ajaz Hussain Ph.D.

Helen Winkle

 

5:00 Adjourn