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 21^st 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