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HIV-Related Advisory Committees

For up-to-date information about upcoming FDA Advisory Committee meetings, please use the FDA Advisory Committe Information Line. The service provides recorded messages with date, location, and topic information about upcoming meetings.

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2012

Topic: Blood Donor Deferral for MSMs, Committee Update
Date: May 16, 2012
Committee: Blood Products Advisory Committee

  • Committee update on HHS activities related to the evaluation of the donor deferral policy for men who have had sex with other men Webcast Video disclaimer icon . You will need to scroll the time counter (directly below the video window) to 5:42. (5 hours 46 minutes)

 

Topic: OraQuick In-Home HIV Test
Date: May 15, 2012
Committee: Blood Products Advisory Committee

 

Topic: Fixed-dose combination tablet of elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil fumarate
Date: 5/11/2012
Committee: Antiviral Drugs Advisory Committee

 

Topic: TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet indication for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection
Date: 5/10/2012
Committee: Antiviral Drugs Advisory Committee

 

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2010

 

Topic: Egrifta (tesamorelin) for daily injection to induce and maintain a reduction of excess abdominal fat in human immunodeficiency virus (HIV)infected patients with lipodystrophy
Date: 5/27/2010
Committee: Endocrinologic and Metabolic Drugs Advisory Committee

 

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2009

 

Topic: Selzentry - Efficacy supplement for maraviroc 300 milligram tablets, Pfizer, Inc., proposing a new indication for the treatment of antiretroviral-naive patients with chemokine (c-c motif) receptor 5 (CCR5)-tropic human immunodeficiency virus (HIV)
Date 10/8/2009
Committee: Antiviral Drugs Advisory Committee

 

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2008

There were no FDA advisory committee meetings directly related to HIV/AIDS during 2008

 

 

Topic; Premarket approval application for the FC2 Female Condom, sponsored by the Female Health Company. This device is indicated to help prevent HIV/AIDS and unintended pregnancy.
Date 12/11/2008
Committee: Obstetrics and Gynecology Devices Panel

 

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2007

 

Topic: Isentress (raltegravir potassium), integrase inhibitor 400 milligram tablets (NDA) 22-145 , Merck & Co., Inc., for the treatment of Human Immunodeficiency Virus-1 (HIV-1) infection in combination with other antiretroviral agents in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
Date:9/5/2007

Committee: Antiviral Drugs Advisory Committee

 

 

Topic: Selzentry (maraviroc), 300 milligram tablets (NDA) 022-128 (Pfizer, Inc.), proposed for the treatment of antiretroviral-experienced patients with chemokine (c-c motif) receptor 5 (CCR5)--tropic human immunodeficiency virus (HIV)
Date: 4/24/2007
Committee: Antiviral Drugs Advisory Committee

 

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2006

 

Topic: Clinical trial design issues in the development of products for the treatment of chronic hepatitis C infection
Date: 10/19-20/2006
Committee: Antiviral Drugs Advisory Committee

 

Topic: Radiesse, a sterile, non-pyrogenic, flexible, semi-solid cohesive granular implant containing calcium hydroxylapatite granules in a gel of glycerine, water and sodium carboxymethylcellulose, manufactured by BioForm Medical, Inc.
Date: 8/24/2006
Committee: General and Plastic Surgery Devices Panel

 

Topic: Proposed Studies to Support the Approval of Over-the-Counter (OTC) Home-Use HIV Test Kits
Date: 3/10/2006
Comittee: Blood Products Advisory Committee

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2005

 

Topic: An approach for home-use rapid HIV test kits (for over-the-counter (OTC) availability of the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for use with oral fluid specimens), and a committee update on: draft guidance on nucleic acid testing (NAT) for human immunodeficiency virus (HIV)-1 and hepatitis C virus (HCV): Testing, product disposition, and donor deferral and re-entry
Date: 11/3/2005
Committee: Blood Products Advisory Committee

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Topic: Aptivus (Tipranavir) 250 milligrams (mg) capsules, new drug application (NDA) 021-814 (Boehringer Ingelheim Pharmaceuticals, Inc.), indicated for the treatment of patients with HIV.
Date: 5/19/2005
Committee: Antiviral Drugs Advisory Committee

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2004

 

Topic: Review of Thailand HIV vaccine phase III trial for an HIV I recombinant canarypox-vectored vaccine and a recombinant gp 120 B/E CHO cells with alum vaccine.
Date: 9/23/2004
Committee: Vaccines and Related Biological Products Advisory Committee

 

Topic: Premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in human immunodeficiency virus (HIV) positive patients (Dermik Laboratories) (Poly L- Lactic Acid, Sculptra, also known in Europe as New Fill).
Date: 3/25/2004
Committee: General and Plastic Surgery Devices Panel (Center for Devices and Radiological Health)

 

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2003

 

Topic: Clinical trial design issues in the development of topical microbicides for the reduction of HIV transmission.
Date: 8/20/2003

Committee: Antiviral Drugs Advisory Committee

 

Topic: Reyataz™ (atazanavir sulfate) capsules, new drug application (NDA) 21-567, (Bristol-Myers Squibb Company), for the treatment of human immunodeficiency virus infection.
Date: 5/13-14/2003

Committee: Antiviral Drugs Advisory Committee

Date: 5/14/2003

 

Topic: Issues related to the development of antiretroviral drugs in human immunodeficiency virus (HIV)-infected and HIV-exposed neonates younger than 4 weeks of age
Date 3/3/2003
Committee: Anti-Infective Drugs Advisory Committee, Pediatric Subcommittee

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2002

There were no FDA advisory committee meetings directly related to HIV/AIDS during 2002

 

2001

 

Topic: Lentiviral vector gene transfer product for treatment of people with HIV
Date 10/24-25/2001

Committee: Biological Response Modifiers Advisory Committee

 

Topic: Viread™ (tenofovir disoproxil fumarate) Tablets, new drug application (NDA) 21-356 (Gilead Sciences) for the treatment of human immunodeficiency virus (HIV) infection,
Date: 10/3/2001
Committee: Antiviral Drugs Advisory Committee

 

 

Topics: Rapid HIV Tests and Serological Test Results
  • Clinical Trial Design and Performance Standards for Approval of Rapid HIV Tests
  • Re-entry for Donors Deferred Because of HIV or HCV NAT or Serological Test Results
  • CLIA Criteria for In Vitro Diagnostic Tests: Applicability of Waivers to HIV Rapid Tests
Date: 6/14-15/2001
Committee: Blood Products Advisory Committee

 

Topic: Valcyte (valganciclovir hydrochloride) tablets, 450mg, Syntex (USA) LLC, NDA 21-304, proposed for treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Date: 2/27/2001
Committee: Antiviral Drugs Advisory Committee

 

Topic: Clinical trial design issues for patients with HIV-1 infection who have limited therapeutic options
Date: 01/11/2001

Committee: Antiviral Drugs Advisory Committee

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2000

 

Topic: The use of surrogate markers in early development of immunomodulatory agents for the treatment of patients with HIV.
Date: 10/16/2000

Committee: Antiviral Drugs Advisory Committee

 

Topic: FDA blood or plasma donor deferral policy related to men who have had sex with men (MSMs) -- Blood Donor Deferral for MSMs
Date: 9/14/2000
Committee: Blood Products Advisory Committee

 

Topic: The role of pharmacokinetic data in the evaluation of new formulations, alternative dosing regimens and new dosing combinations of approved antiretroviral drugs.
Date: 7/25/2000
Committee: Antiviral Drugs Advisory Committee

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1999

 

Topic: The role of genotypic and phenotypic HIV resistance testing in antiretroviral drug development
Date: 11/2-3/1999
Committee: Antiviral Drugs Advisory Committee

 

Topic: Adefovir, new drug application (NDA) 20- 993, adefovir dipivoxil (Gilead Sciences Inc.), for the treatment of human immunodeficiency virus infection.
Date 11/1/1999
Committee: Antiviral Drugs Advisory Committee
Topic: Discussion of issues related to the potential applicability of information from non-U.S. studies of prevention of perinatal human imunodeficiency virus transmission to U.S. clinical settings.
Date: 10/4/1999

 

Committee: Antiviral Drugs Advisory Committee

 

Topic: Reclassification of Human Immunodeficiency Virus (HIV) drug sensitivity assays.
Date: 09/17/1999

Committee: Blood Products Advisory Committee

The agency described the general classification of biological products, and asked the committee for a recommendation for classification of viral resistance assays. The classification assignment determines how these assays are regulated by the agency.

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1998

 

Topic: Ziagen (abacavir sulfate), new drug application (NDA) 20-977/20-978 to treat HIV infection
Date: 11/2/1998
Committee: Antiviral Drugs Advisory Committee

Transcript (Rich Text Format)
Transcript (PDF - 166 KB)

 

Topic: Presentations on general regulatory procedures and policies, including overview of the Food and Drug Administration Modernization Act of 1997
Date: 7/14/1998
Committee: Antiviral Drugs Advisory Committee

Transcript (PDF- 4 MB)

 

Topic: NTZ (nitazoxanide), new drug application (NDA) 20-871 for treatment of Cryptosporidiosis
Date: 5/6/1998
Committee: Antiviral Drugs Advisory Committee

Transcript (Rich Text Format)
Transcript (PDF - 12 MB)

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1997

 

Topic: Utility of plasma HIV RNA as an endpoint in clinical trials for drugs to treat HIV infection, and review of pediatric HIV data
Date: 7/14-15/1997
Committee: Antiviral Drugs Advisory Committee

Transcript  (PDF Format - 12 MB)

 

Topic: Zyrkamine (mitoguazone dihydrochloride, ILEX Oncology), indicated for treatment of AIDS-related non-Hodgkins lymphoma in patients who have been previously treated with at least one potentially curative regimen.
Date: 6/23/1997
Committee: Oncologic Drugs Advisory Committee

Transcript (Rich Text Format)
Transcript (PDF)
Additional Documents: Slides (PDF)

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1996

Transcripts from 1996 meetings are available from the Freedom of Information Office.

 

Topic: Rescriptor (delavirdine), new drug application (NDA) 20-705 for the treatment of HIV infection
Date: 11/22/1996
Committee: Antiviral Drugs Advisory Committee

Transcripts from 1996 meetings are available from the Freedom of Information Office.

 

Topic: The use of microbicidal topical vaginal agents against sexually transmitted chlamydia trachomatis and Neisseria gonorrhoeae. Discussion on guidelines for the development of vaginal products for preventing the transmission of HIV. Discussion on proposals and guidances for clinical efficacy studies on marketed OTC vaginal spermicides.
Date: 11/20-22/1996
Committee: Joint meeting of the Nonprescription Drugs Advisory Committee, the Antiviral Drugs Advisory Committee, the Anti-Infective Drugs Advisory Committee and the Advisory Committee for Reproductive Health

Transcripts from 1996 meetings are available from the Freedom of Information Office.

 

Topic: Viramune (nevirapine), new drug application (NDA) 20-636 for the treatment of HIV infection
Date: 6/7/1996
Committee: Antiviral Drugs Advisory Committee

Transcripts from 1996 meetings are available from the Freedom of Information Office.

 

Topic: Vistide (cidofovir, intravenous), new drug application (NDA) 20-638 for the treatment of CMV retinitis
Date: 3/15/1996
Committee: Antiviral Drugs Advisory Committee joint meeting with Ophthalmic Drugs Subcommittee

Summary Minutes
Transcripts from 1996 meetings are available from the Freedom of Information Office.

 

Topic: Serostim (somatropin), new drug application (NDA) 20-604 for the treatment of AIDS wasting or cachexia
Date: 3/1/1996
Committee: Endocrinologic and Metabolic Drugs Advisory Committee joint meeting with Antiviral Drugs Advisory Committee

Transcripts from 1996 meetings are available from the Freedom of Information Office.

 

Topic: Crixivan (indinavir capsules), new drug application (NDA) 20-685 for the treatement of HIV infection
Date: 3/1/1996
Committee: Antiviral Drugs Advisory Committee

Transcripts from 1996 meetings are available from the Freedom of Information Office.

 

Topic: Norvir (ritonavir), new drug application (NDA) 20-659/20-68 for the treatement of HIV infection
Date: 2/29/1996

Committee: Antiviral Drugs Advisory Committee

Transcripts from 1996 meetings are available from the Freedom of Information Office.

 

Topic: Retrovir (zidovudine), new drug application (NDA) 19-665/19-919
Date: 2/28/1996
Committee: Antiviral Drugs Advisory Committee

Transcripts from 1996 meetings are available from the Freedom of Information Office.

 

Topic: Discussion of recent studies with nucleoside analogues for the treatment of HIV infection.
Date: 2/28/1996

Committee: Antiviral Drugs Advisory Committee

Data from AIDS Clinical Trials Group (ACTG) Study 175, the Delta studies, and other relevant studies. Data from Videx new drug application (NDA) 20-154, 20-155 and 20-156, Retrovir NDA 19-655 and 19-910 and HIVID NDA 20-199 were discussed.

Transcripts from 1996 meetings are available from the Freedom of Information Office.

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