BLOOD PRODUCTS ADVISORY COMMITTEE
76th Meeting – June 19-20, 2003
Gaithersburg, MD 20877
Thursday, June 19, 2003
8:00 a.m. Welcome, Statement of Conflict of Interest, Announcements
8:05 a.m. Committee Updates
· Medical Device User Fee and Modernization Act (MDUFMA) – Mary Elizabeth Jacobs, PhD – 5'
· White Particulate Matter in Blood Bags – Sharyn Orton, PhD- 15'
· Safety Reporting Requirements for Human Drug and Biological Products – Richard Lewis, PhD 5'
· Bovine Spongiform Encephalopathy (BSE) in Canada – Pedro Piccardo, MD -10'
- Baxter Labs. Presentation –15'
9:05 a.m. Open Committee Discussion
A. Introduction and Background – Alan Williams, PhD, Director, Division of Blood Applications, OBRR –15'
B. Epidemiology and Pathogenesis – Mark Denison, MD, Vanderbilt University -15'
C. SARS: Canadian studies (epidemiology and virology) – Anton Andonov, MD, Canadian Science Center for Human and Animal Microbiology, Health Canada - 15'
10:15 a.m. BREAK
11:45 a.m. Open Committee Discussion
12:30 p.m. LUNCH
1:30 p.m. Open Committee Discussion
II. West Nile Virus (WNV) - Informational
A. Introduction – Hira Nakhasi, PhD, Director, Division of Emerging and Transfusion Transmitted Diseases – 5'
B. Epidemiology and Surveillance Update – Anthony Marfin, MD, Centers for Disease Control and Prevention – 15'
C. Status of WNV test, Lot release and validation panel development – Indira Hewlett, PhD, Chief, Laboratory of Molecular Virology, DETTD, OBRR – 15'
D. Revised WNV Guidance – Sharyn Orton, PhD, Consumer Safety Officer, Division of Blood Applications – 15'
2:30 p.m. OPEN PUBLIC HEARING
Presentations from manufacturers –6' each
3:30 p.m. Open Committee Discussion
E. Committee Discussion
4:30 p.m. RECESS (until 8:30 a.m. Friday, June 20, 2003)
Friday, June 20, 2003
8:30 a.m. Open Committee Discussion
III. Discussion on Recovered Plasma
A. Introduction and Background – Elizabeth Callaghan, MS, SBB (ASCP), Deputy Director, Division of Blood Applications, OBRR – 10'
B. Presentation – Robert Lunsford, Plasma Resource Director, ZLB (PPTA) – 25'
C. Presentation – Kay Gregory, AABB – 25'
9:30 a.m. OPEN PUBLIC HEARING
10:30 a.m. BREAK
11:00 a.m. Open Committee Discussion
D. FDA Current Thinking and Questions for the Committee – Elizabeth Callaghan – 10'
E. Committee Discussion and Recommendations
12:00 NOON LUNCH
1:00 p.m. Open Committee Discussion
IV. Vaccinia Immune Globulin Intravenous (VIGIV): Current Thinking and Indications for Use - Informational- 30'
A. Presentation – Dorothy Scott, MD
2:00 p.m. OPEN PUBLIC HEARING
2:30 p.m. Open Committee Discussion
B. Committee Discussion
3:00 p.m. ADJOURNMENT