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Dockets Management

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Food and Drug Administration

Blood Products Advisory Committee Meeting

March 10, 2006


Proposed Studies to Support the Approval of Over-the-Counter (OTC) Home-Use HIV Test Kits, Elliot P. Cowan, Ph.D. (ppt) (htm) (Added 4/7/06)

Clinical Experience with Approved Rapid HIV Tests, Bernard M. Branson, MD (ppt)

Office of Blood Research and Review Overview of Research, Jay Epstein (ppt)

Division of Hematology, Basil Golding (ppt)

Laboratory of Biochemistry and Vascular Biology, Abdu Alayash, Ph.D. (ppt)

Laboratory of Cellular Hematology, Jaro Vostal MD, Ph.D. (ppt)

Cell Membrane Micropharticles in Blood and Blood Products: Potentially Pathogenic Agents and Biomarkers, Jan Simak, Ph.D. (ppt)

- Open Public Hearing Speakers -

What End Users Want From an Over-The-Counter HIV Rapid Test in Hong Kong, MedMira (ppt)

FDA's Home HIV Test Criteria, Elliott Millenson (ppt)

Testimony of Elliott J. Millenson on the subject of AIDS Testing (pdf) (htm) (Added 4/7/06)

OraQuick ADVANCE™ HIV 1/2 Antibody Test (ppt)

HIV Testisng in Acute Care Settings, Rich Rothman, MD, Ph.D. (ppt)

Over the Counter HIV Testing Estimating the Public Health Benefit - Recommendations for Required Accuracy, Freya Spielberg, MD, MPH (ppt)

Fingerstick Whole Blood Sample for HIV OTC Test, Fiona Campbell (ppt)

HIV Screening in an Urban emergency Department, Douglas White, MD (ppt)

Rapid HIV Testing in NJ, Evan Cadoff (ppt)

OTC Home-Use HIV Kits: ASM Considerations, Patricia Charache (ppt)

PUBLIC COMMENT, James Sykes, The AIDS Institute (pdf) (htm) (Added 4/7/06)

Testimony on HIV Home Testing, National Black Leadership Commission on AIDS, Inc. (NBLCA) (pdf) (htm) (Added 4/7/06)

Thomas M. Donohue, Jr., Executive Director, Founder, Who's Positive (pdf) (Added 4/7/06)

Statement by Latino Commission on AIDS to Blood Products Advisory Committee to Discuss Approaches to Over the Counter Home Use HIV Test, Latino Commission on AIDS (pdf) (htm) (Added 4/7/06)

Comments by A. David Paltiel, MBA, PhD, Yale School of Medicine  and Rochelle P. Walensky, MD, MPH, Harvard Medical School (htm) (Added 4/7/06)

Comments by Assocation of Public Health Laboratories (APHL), Scott Becker, MS and Jane Getchell, DrPH (pdf) (Added 4/7/06)

Statement by Committee of Ten Thousand (pdf)

Testimony on HIV Testing Over the Counter, Dr. David A. Reznik, Grady Health System (pdf)

Testimony by Laird Petersen, Chief of Staff, IL State Representative Larry McKeon (pdf)

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