For Patients

HIV Related Advisory Committee Meeting History 1996 - Present

2017
  • During the April 4, 2017, the committee heard an update presentation on a summary of responses to Docket FDA-2016-N-1502: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.

2016
  • No HIV-related FDA advisory committee meetings.

2015
  • No HIV-related FDA advisory committee meetings.


2014
  • No HIV-related FDA advisory committee meetings.


 2013
  • No HIV-related FDA advisory committee meetings.


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

  • 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: May 12, 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: May 10,2012
    Committee: Antiviral Drugs Advisory Committee


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: May 27, /2010
    Committee: Endocrinologic and Metabolic Drugs Advisory Committee


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: October 8, 2009
    Committee: Antiviral Drugs Advisory Committee


2008
  • Topic: Premarket approval application for the FC2 Female Condom, sponsored by the Female Health
    Date: December 11, 2008
    Committee: Obstetrics and Gynecology Devices Panel


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: September 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: April 24, 2007
    Committee: Antiviral Drugs Advisory Committee

2006 
  • Topic: Clinical trial design issues in the development of products for the treatment of chronic hepatitis C infection
    Date: October 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.
    Date: August 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: March 10, 2006
    Committee: Blood Products Advisory Committee

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: November 3, 2005
    Committee: Blood Products Advisory Committee
  • 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: May 19, /2005
    Committee: Antiviral Drugs Advisory Committee

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: September 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: March 25, 2004
    Committee: General and Plastic Surgery Devices Panel (Center for Devices and Radiological Health)


2003
  • Topic: Clinical trial design issues in the development of topical microbicides for the reduction of HIV transmission.
    Date: August 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: May 13-14, 2003
    Committee: Antiviral Drugs Advisory Committee

  • 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: March 3, 2003
    Committee: Anti-Infective Drugs Advisory Committee, Pediatric Subcommittee


2002
  • No HIV-related advisory committee meetings.


2001
  • Topic: Lentiviral vector gene transfer product for treatment of people with HIV
    Date: October 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: October 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: June 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 AIDS.
    Date: February 27, 2001
    Committee: Antiviral Drugs Advisory Committee

  • Topic: Clinical trial design issues for patients with HIV-1 infection who have limited therapeutic options
    Date: January 11, 2001
    Committee: Antiviral Drugs Advisory Committee

2000 
  • Topic:The use of surrogate markers in early development of immunomodulatory agents for the treatment of patients with HIV.
    Date: October 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: September 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: July 25, 2000
    Committee: Antiviral Drugs Advisory Committee


1999
  • Topic: The role of genotypic and phenotypic HIV resistance testing in antiretroviral drug development
    Date: November 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: November 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: October 4, 1999
    Committee: Antiviral Drugs Advisory Committee
  • Topic: Reclassification of Human Immunodeficiency Virus (HIV) drug sensitivity assays.
    Date: September 17, 1999
    Committee: Blood Products Advisory Committee


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

  • Topic: Presentations on general regulatory procedures and policies, including overview of the Food and Drug Administration Modernization Act of 1997
    Date: July 14, 1998
    Committee: Antiviral Drugs Advisory Committee
  • Topic: NTZ (nitazoxanide), new drug application (NDA) 20-871 for treatment of Cryptosporidiosis
    Date: May 6, 1998
    Committee: Antiviral Drugs Advisory Committee

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: July 14-15, 1997
    Committee: Antiviral Drugs Advisory Committee

  • 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: June 23, 1997
    Committee: Oncologic Drugs Advisory Committee

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: November 22, 1996
    Committee: Antiviral Drugs Advisory Committee

  • 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: November 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

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

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

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

  • Topic: Crixivan (indinavir capsules), new drug application (NDA) 20-685 for the treatement of HIV infection
    Date: March 1, 1996
    Committee: Antiviral Drugs Advisory Committee
  • Topic: Norvir (ritonavir), new drug application (NDA) 20-659/20-68 for the treatement of HIV infection
    Date: February 29, 1996
    Committee: Antiviral Drugs Advisory Committee

  • Topic: Retrovir (zidovudine), new drug application (NDA) 19-665/19-919
    Date: February 28, 1996
    Committee: Antiviral Drugs Advisory Committee
  • Topic: Discussion of recent studies with nucleoside analogues for the treatment of HIV infection.
    Date: February 28, 1996
    Committee: Antiviral Drugs Advisory Committee

Page Last Updated: 01/08/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English