6/17/2003

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