FDA Webview

Federal Register Notice: FDA’s Blood Products Advisory will meet 3/18, from 8 a.m. to 5 p.m. and on 3/19, from 8 a.m. to 3 p.m. at the Holiday Inn, Gaithersburg, MD. On 3/18, the committee will discuss clinical trials for licensing hepatitis B immune globulin as treatment to prevent hepatitis B virus liver disease following liver transplantation in HBV+ recipients. The committee will also hear updates on: (1) Summary of meeting of the Public Health Service Advisory Committee on Blood Safety and Availability; (2) summary of the meeting of the Transmissible Spongiform Encephalopathies Advisory Committee; (3) current thinking on draft guidance for nucleic acid testing (NAT) for human immunodeficiency virus (HIV) and hepatitis C virus (HCV): Testing, product disposition, and donor deferral and re-entry; (4) current thinking on guidance for use of NAT on pooled and individual samples from donors of whole blood and blood components to adequately and appropriately reduce the risk of transmission of HIV-1 and HCV; and (5) current thinking on variances to address the specificity issues of Ortho HBsAg 3.0 assays. The committee will also discuss supplemental testing for HIV and HCV.

On 3/19, the committee will provide recommendations on platelet apheresis quality control and hear presentations about the site visit report on the research programs at the Laboratory of Hepatitis and Emerging Bacterial Agents and the Laboratory of Bacterial, Parasitic, and Unconventional Agents. Contact Linda A. Smallwood, (301) 827-3514. To view this notice, click here.