Dockets Management

---

Food and Drug Administration

Blood Products Advisory Committee

November 3, 2005

Slides

Updates on West Nile virus and Blood Safety, Hira Nakhasi, Ph.D., FDA ( htm ) ( ppt )

West Nile Virus Epidemiology & Surveillance Update 2005, Theresa Smith, M.D., MPH, CDC ( htm ) ( ppt )

Draft Guidance on NAT for HIV-1 and HCV: Testing, Product Disposition, and Donor Deferral and Reentry, Paul Mied, Ph.D., FDA ( htm ) ( ppt )

October 31, 2005 TSE Advisory Committee Meeting Summary, David Asher, M.D., FDA ( htm ) ( ppt )

The Secretary's Advisory Committee on Blood Safety and Availability Update ( htm ) ( ppt )

Reentry for Donors Deferred based on Anti-HBc Test Results ( htm ) ( ppt )

Anti-HBc Testing and Donor Reentry Results of a Pilot Study, Susan Stramer, Ph.D., American Red Cross ( htm ) (ppt)

Approaches to Validation of Over-the-Counter (OTC) Home-Use HIV Test Kits, Elliot Cowan, Ph.D., FDA (htm ) ( ppt )

An Approach for a Rapid HIV Antibody Home-Use Oral Fluid Test, OraSure Technologies, ( ppt ) ( pdf )

Changes in HIV Testing Practices and Counseling Recommendations, Bernard Branson, M.D., CDC ( ppt) ( htm)

Quality System Considerations for Over-the-Counter HIV Testing, Devery Howerton, Ph.D., CDC ( htm ) ( ppt )

Psychological/Social Issues Associated with HIV Testing and OTC Home-Use HIV Tests, Joseph Inungu, M.D., Dr.PH, Central Michigan University ( htm ) ( ppt )

Office of in Vitro Diagnostic Device Evaluation and Safety, Arleen Pinkos, FDA ( htm ) ( ppt )

Open Public Hearing

List of Speakers ( pdf )

Over the Counter HIV Testing - A Technology Whose Time Has Come, Freya Spielberg, M.D., MPH (htm) (ppt )

American Society for Microbiology, Position on Home Use HIV-1 Testing, Patricia Charache, M.D. ( htm ) ( ppt )

Home Access Health Corporation ( htm ) ( ppt )