6/19/2003

BLOOD PRODUCTS ADVISORY COMMITTEE

76th Meeting June 19-20, 2003

Hilton Gaithersburg, 620 Perry Parkway

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

I. Severe Acute Respiratory Syndrome (SARS) Informational

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

 

10:45 a.m. D. FDA Current Thinking Alan Williams, PhD 20'

 

11:05 a.m. OPEN PUBLIC HEARING

 

 

11:45 a.m. Open Committee Discussion

E. 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