FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

 

 

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

 

 

November 28-29, 2001

Holiday Inn, Bethesda

 

DRAFT AGENDA

 

 

 

Wednesday, November 28, 2001

 

8:30 am Session 1, 2, 3 - CLOSED SESSIONS

 

12:30 pm Session 4 - OPEN Session

Efficacy Trial Endpoints for Vaccines for the Prevention of Human Papilloma Virus

 

12:30 Call to Order, Dr. Robert S. Daum,

Introductions, Administrative Matters Committee Chair

12:45 Introduction to Session and Dr. Karen Goldenthal, FDA

Presentation of Questions or Dr. Douglas Pratt, FDA

1:00 Natural History and Virology Dr. Beth Unger

 

1:45 Clinical Management/Natural History Dr. Edward Wilkinson

of Cervical Dysplasia and Related Findings

 

2:30 Break

2:45 Endpoints Dr. Karen L. Goldenthal, FDA

Re-introduction of Questions and Q & A

 

3:30 Open Public Hearing

 

4:45 Adjourn for the Day

 


FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

 

 

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

 

 

November 28-29, 2001

Holiday Inn, Bethesda

 

DRAFT AGENDA

 

 

 

Thursday, November 29, 2001

 

8:30 AM Session 4 Open Session -- Continued

 

8:30 Call to Order Dr. Robert S. Daum

 

8:40 Committee Discussion and Recommendations

 

12:00 noon Lunch

 

1 PM Session 5 Open Session

Briefing on Activities in the Laboratory of Bacterial Toxins

 

1:00 Organizational Structure and Overview of Dr. Richard Walker, FDA

Research and Regulatory Responsibilities in the

Division of Bacterial, Parasitic and Allergenic Products

 

 

1:10 Organizational Structure and Overview of Regulatory Dr. Willie Vann, FDA

Responsibilities in the Laboratory of Bacterial Toxins

 

1:15 Description of Research Activities Dr. Willie Vann, FDA

 

1:25 Description of Research Activities Dr. Michael Schmitt

 

1:35 End of Open Sessions

 

 

 

1:45 Session 6 CLOSED SESSION

 

2:30 End of Closed Session; Adjournment of Meeting