For Consumers
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.
Search by Medication/Topic or by year
- Adefovir (adefovir dipivoxil) 11/1/99
- Aptivus (tipranavir/ritonavir) May 19, 2005
- Blood Donor Deferral for MSMs 9/14/2000
- Blood Donor Deferral for MSMs, Committee Update, 5/16/2012
- Clinical trial design issues in the development of products for the treatment of chronic hepatitis C infection 10/19-20/2006
- Clinical trial design-limited therapeutic options 01/11/2001
- Crixivan (indinavir) 3/1/1996
- Egrifta (tesamorelin) 5/27/2010
- Eltvitegravir/Combistat/Emtricitabine/Tenofovir DF Single Tablet Regimen 5/11/2012
- Endpoints & plasma HIV RNA 7/14-15/1997
- FC2 Female Condom 12/11/2008
- Genotypic & phenotypic HIV resistance testing 11/2-/3/1999
- HIV drug sensitivity assays 09/17/1999
- Hivid (zalcitabine) 2/28/1996
- Immunomodulatory agents & surrogate markers 10/16/2000
- Isentress (raltegravir potassium), integrase inhibitor 9/5/2007
- Lentiviral vector gene therapy 10/24 - 25/2001
- Neonates with HIV 3/3/2003
- Norvir (ritonavir) 2/29/1996
- NTZ (nitazoxanide) 5/6/1998
- OraQuick In-Home HIV Test 5/15/2012 Perinatal HIV transmission 10/4/1999
- Pharmacokinetic data and its role in evaluation of new formulations & dosing regimens 7/25/2000
- Radiesse - (flexible, semi-solid cohesive granular implant) for HIV Lipoatrophy 8/24/2006
- Rapid HIV Test - Over-the-counter (OTC) for Home Use - Proposed Studies to Support Approval 3/10/2006
- Rapid HIV testing - Over-the-counter (OTC) sale and home use - conditions necessary to support approval of a home-use HIV test kit 11/3/2005
- Rapid HIV Tests: Clinical Trial Design and Performance Standards for Approval 6/14-15/2001
- Rapid HIV Tests: Applicability of WaiversCLIA Criteria for In Vitro Diagnostic Tests 6/14-15/2001
- Re-entry for Donors Deferred Because of HIV or HCV NAT or Serological Test Results 6/14-15/2001
- Regulatory procedures & FDAMA overview 7/14/1998
- Rescriptor (delavirdine) 11/22/1996
- Retrovir (zidovudine) 2/28/1996
- Reyataz (atazanavir) 5/13-14/2003
- Sculptra (poly L-lactic acid) facial filler implant 3/25/2004
- Selzentry - (maraviroc) for the treatment of antiretroviral-experienced patients with chemokine (c-c motif) receptor 5 (CCR5)--tropic human immunodeficiency virus (HIV) 4/24/2007
- Selzentry - (maraviroc) new indication for antiretroviral-naive patients 10/8/2009
- Serostim (somatropin) 3/1/1996
- Topical microbicides & clinical trial design 8/20/2003
- TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet indication for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection 5/10/2012
- Vaginal topical microbicides - development of vaginal products for preventing the transmission of HIV 11/20-22/1996
- Vaccine phase III trial review 9/23/2004
- Valcyte (valganciclovir) 2/27/2001
- Videx (didanosine) 2/28/1996
- Viramune (nevirapine) 6/7/1996
- Viread (tenofovir) 10/24-25/2001
- Vistide (cidofovir) 3/15/1996
- Ziagen (abacavir) 11/2/1998
- Zyrkamine (mitoguazone) for treatment of AIDS-related non-Hodgkins lymphoma 6/23/1997
Search by year
1996 | 1997 | 1998 | 1999 | 2000 | 2001 | 2002 | 2003 | 2004 | 2005 | 2006 | 2007 | 2008 | 2009 |
| 2010 | 2012 |
Search FDA Advisory Committee page for other topics and resources
Viewing Files
- Some of these documents are in Portable Document Format (PDF) to retain the original format. To view or print these documents, you must use the free Adobe Acrobat viewer. Acrobat is free and available directly from Adobe's Website with full installation instructions. Where "(PDF)" is the link, it indicates that this link accesses the PDF formatted file.
- Microsoft Word files can be viewed with that application or with a free, downloadable document viewer available from the Microsoft Website. If you need additional information about viewing these types of files, go to General Help for Accessing Files.
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 . 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
Draft Agenda (PDF - 21KB) Issue Summary (PDF - 194KB) Topic: Evaluation of Potential New Plasma Products Manufactured Following Storage at Room Temperature for up to 24 Hours (PDF - 296KB) - Meeting Announcement
Member Roster (PDF - 75KB) Questions for the Committee (PDF - 17KB) References (PDF - 24KB) OraQuick® In-Home HIV Test Sponsor Briefing Document (PDF - 397KB)
Persons with disabilities having problems accessing the PowerPoint file may call 301-827-0314 for assistance.- Waivers for Conflicts of Interest
- Webcasts
Topic: Fixed-dose combination tablet of elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil fumarate
Date: 5/11/2012
Committee: Antiviral Drugs Advisory Committee
- May 11, 2012: Antiviral Drugs Advisory Committee Meeting Announcement
Draft Agenda for the May 11, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 41KB) Draft Questions for the May 11, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 21KB) Draft Meeting Roster for the May 11, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 26KB) Committee Roster for the May 11, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 30KB) Briefing Information for the May 11, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting Final Agenda for the May 11, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 43KB) Final Questions for the May 11, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 22KB) Final Meeting Roster for the May 11, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 15KB) Slides for the May 11, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting
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
- May 10, 2012: Antiviral Drugs Advisory Committee Meeting Announcement
UPDATED TIME, AGENDA AND PUBLIC PARTICIPATION INFORMATION: May 10, 2012: Antiviral Drugs Advisory Committee Meeting Announcement Draft Agenda for the May 10, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 30KB) Draft Questions for the May 10, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 21KB) Draft Meeting Roster for the May 10, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 48KB) Committee Roster for the May 10, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 24KB) - Webcast Information for the May 10, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 30KB)
Briefing Information for the May 10, 2012 Meeting of the Antiviral Drugs Advisory Committee Final Agenda for the May 10, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 28KB) Final Questions for the May 10, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 19KB) Final Meeting Roster for the May 10, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting (PDF - 130KB) Slides for the May 10, 2012 Antiviral Drugs Advisory Committee (AVDAC) Meeting
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
- May 27, 2010: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
- Briefing Information for the May 27, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee
- Draft Agenda for the May 27, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF - 32KB)
- Draft Questions for the May 27, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF - 27KB)
- Draft Meeting Roster for the May 27, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF - 81KB)
- Draft Committee Roster for the May 27, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF - 30KB)
Transcript for the May 27, 2010 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (PDF - 897KB)
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
- October 8, 2009: Antiviral Drugs Advisory Committee Meeting Announcement
- Draft Agenda for the October 8, 2009 Meeting of the Antiviral Drugs Advisory Committee (PDF - 96KB)
- Meeting Roster for the October 8, 2009 Meeting of the Antiviral Drugs Advisory Committee (PDF - 82KB)
- Committee Roster for the October 8, 2009 Meeting of the Antiviral Drugs Advisory Committee (PDF - 35KB)
- Briefing Information for the October 8, 2009 Meeting of the Antiviral Drugs Advisory Committee
- Questions for the October 8, 2009 Meeting of the Antiviral Drugs Advisory Committee (PDF - 22KB)
- Transcript for the October 8, 2009 Meeting of the Antiviral Drugs Advisory Committee (PDF - 3119KB)7
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
- Draft Agenda (PDF) (15 KB)
- Briefing Information
- Draft Questions (PDF) (35 KB)
- Draft Roster (PDF) (21 KB)
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
- Notice of Meeting (View document in PDF format) (52 KB))
- Final Agenda (PDF) (15.8KB)
- Draft Agenda (PDF) (91 KB)
- Meeting Roster (Final) (PDF) (51.4 KB)
- Meeting Roster (Draft) (PDF) (80.6 KB)
- Committee Roster (PDF) (87.1 KB)
- Final Questions (PDF) (12.8 KB)
- Draft Questions (PDF) (11.5 KB)
- Briefing Information
- Slides
- Transcript: (Part1.pdf) (289 KB), (Part2.pdf) (249 KB), (Part3.pdf) (181 KB)
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
- Notice of Meeting (View document in PDF format [51 KB])
- Nature and Basis Statements of Conflict(s) of Interest for April 24, 2007 (htm)
- Change in Meeting Location for April 24, 2007 Meeting (PDF format) (15KB)
- Draft Agenda (PDF format) (99 KB)
- Rosters : Committee (PDF format) (78 KB), Meeting (PDF format) (80 KB)
- Briefing Information
- Final Questions for April 24, 2007 Meeting (PDF format ) (12 KB)
- Final Report - Collaborative Approaches to HIV Drug Development: Planning for Long-Term Monitoring of Seafetly in CCR5 Antagonist Development (Report of an FDA/Forum on Collaborative HIV Research Joint Public Meeting) (PDFformat) (431 KB)
- Slides
- Summary Minutes (PDFformat) (39) KB)
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
- Notice of Meeting (View document in PDF format [56KB])
- Nature and Basis Statements of Conflict(s) of Interest for October 19-20, 2006 Meeting
- Draft Agenda for October 19, 2006 Meeting (PDF58 KB)
- Draft Agenda for October 20, 2006 Meeting (PDF 57 KB)
- Briefing Information
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
- Notice of Meeting [View document in PDF format (51 KB)]
- Nature and Basis Statements of Conflict(s) of Interest
- Agenda for August 24 and 25, 2006 Meeting (PDF 17 KB )
- Roster (PDF 14 KB)
- Briefing Information
- Questions for the Committee - Morning (PDF 11 KB)
- Questions for the Committee-- Afternoon (PDF 12 KB)
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
- Notice of Meeting (PDF 343 KB)
- Briefing Information/Issue Summary (PDF)
- Nature and Basis Statements of Conflict(s) of Interest
- Draft Agenda (PDF 34 KB)
- Final Agenda for March 9-10, 2006 (PDF 1.5 MB)
- Roster for March 9-10, 2006 (PDF 652 KB)
- Temporary Voting Members for March 9-10, 2006 (PDF 244 KB)
- Guest Speakers for March 9-10, 2006 (PDF 275 KB)
- Questions for the Committee (PDF 15 KB)
- Slides
- Transcripts for March 9, 2006 (PDF 133MB)
Includes: Workshop Summary--Behavior-Based Donor Deferrals in the NAT ERA (page 44) - Transcripts for March 10, 2006 (PDF 9 MB)
Proposed Studies to Support the Approval of Over-the-Counter (OTC) Home-Use HIV Test Kits
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
- Notice of Meeting [View document in PDF format (50KB)]
- Briefing Information
- Draft Agenda [View document in PDF format (27 KB)]
- Committee Roster
- Slides
- Approaches to Validation of Over-the-Counter (OTC) Home-Use HIV Test Kits, Elliot Cowan, Ph.D., FDA
- An Approach for a Rapid HIV Antibody Home-Use Oral Fluid Test, OraSure Technologies (PDF 1 MB)
- Changes in HIV Testing Practices and Counseling Recommendations, Bernard Branson, M.D., CDC [View the PowerPoint slides]
- Quality System Considerations for Over-the-Counter HIV Testing, Devery Howerton, Ph.D., CDC [View the PowerPoint slides]
- Psychological/Social Issues Associated with HIV Testing and OTC Home-Use HIV Tests, Joseph Inungu, M.D., Dr.PH, Central Michigan University [View the PowerPoint slides]
- Office of in Vitro Diagnostic Device Evaluation and Safety, Arleen Pinkos, FDA [View the PowerPoint slides]
- Open Public Hearing
- List of Speakers (PDF 354 KB)
- Over the Counter HIV Testing - A Technology Whose Time Has Come, Freya Spielberg, M.D., MPH [View the PowerPoint slides]
- American Society for Microbiology, Position on Home Use HIV-1 Testing, Patricia Charache, M.D. [View the PowerPoint slides]
- Home Access Health Corporation [View the PowerPoint slides]
- Written Statements
- Quick Minutes
- Transcript
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
- Notice of Meeting [View document in PDF format (51 KB)]
- Briefing Information
- Final Agenda [View document in PDF format (40 KB)]
- Draft Agenda [View document in PDF format (17 KB)]
- Committee Roster [View document in PDF format (26 KB)]
- Consultants/Guests Roster [View document in PDF format (19 KB)]
- Final Questions [View document in PDF format (43 KB)]
- Slides
- Summary Minutes [View document in PDF format (62 KB)]
- Transcript (pages 1 - 100) (PDF 624 KB)
- Transcript (pages 101 - 200) (PDF 252 KB)
- Errata (re: page 135) (PDF 10 KB)
- Transcript (pages 201 - 300) (PDF 119 KB)
- Transcript (pages 301 - 406) (PDF 127 KB)
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
- Notice of Meeting [View document in PDF format (48 KB)]
- Final Agenda [View document in PDF (7 KB)] [View document in Word]
- Revised Agenda [View document in PDF (7.1 KB)] [View document in Word]
- Draft Agenda [View document in PDF (7.9 KB)] [View document in Word]
- Roster [View document in PDF (5.5 KB)] [View document in Word]
- Final Questions (PDF (6.2 KB) [View document in Word]
- Briefing Information
- Slides
- Transcript [View document in Word)
- Summary Minutes [View document in PDF (14 KB)] [View document in Word]
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)
- Notice of Meeting [View document in PDF format (48KB)]
- Agenda [View document in PDF format (70KB)] [View document in Word]
- Panel Roster [View document in PDF format (68KB)] [View document in Word]
- Briefing Information
- Slides
- Transcript
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
- Notice of Meeting (PDF -48KB)
- Final Agenda (PDF- 25KB) (Word)
- Draft Agenda (PDF - 51KB) (Word)
- Committee Roster (PDF - 101 KB) (Word)
- Guests/Consultants Roster (PDF - 78 KB) (Word)
- Final Questions (PDF - 79 KB) (Word)
- Draft Questions (PDF - 60 KB) (Word)
- Briefing Informaton
- Slides
- Transcript (PDF) (Word)
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
- Notice of Meeting (PDF -48 KB)
- Final Agenda (PDF - 69 KB) (Word)
- Draft Agenda (PDF - 81 KB)(Word)
- Committee Roster (PDF - 91 KB) (Word)
- Additional Participants (PDF- 82 KB) (Word)
- Final Questions (PDF - 71 KB) (Word)
- Briefing Information
- Slides
- May 13, 2003 Transcript (PDF - 540 KB)
Date: 5/14/2003
Final Agenda (PDF - 70 KB) (Word)
- Draft Agenda (PDF - 75 KB) (Word)
- Committee Roster (PDF - 91 KB) (Word)
- Additional Participants (PDF - 92 KB) (Word)
- Final Questions (PDF - 59 KB) (Word)
- Briefing Information
- Slides
- Transcript (PDF - 426 KB) (Word)
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
- Notice of Meeting (PDF -35 KB)
- Final Agenda (PDF - 86 KB) (Word)
- Draft Agenda (PDF - 98 KB) (Word)
- Final Questions (PDF - 72 KB) (Word)
- Draft Questions (PDF - 54 KB) (Word)
- Committee Roster (PDF - 81 KB) (Word)
- Consultants/Guests Roster (PDF - 64 KB) (Word)
- Briefing Information
- Slides
- Transcript (PDF - 577 KB) (Word)
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
- Draft Agenda
- Final Agenda
- Briefing information
- Questions to the Committee
- Roster
- Slides
- Transcript 10/24/01
- Transcript 10/25/01
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
- Draft Agenda
- Final Agenda
- Roster - Committee
- Roster, consultants and guests
- Questions to the Committee (PDF - 91 KB))
- Briefiing information
- Slides
- Transcript
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
- Agenda (PDF - 661 KB))
- Roster - Committee
- Roster - guests and consultants
- Briefing information
- Slides
- Questions to the Committee
- Transcript (rich text format)
- Transcript (PDF, page 1 - 100) (639 KB)
- Transcript (PDF, page 101 - 200) (627 KB)
- Transcript (PDF, page 201- 221) (392 KB)
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
- Agenda (.doc)
- Agenda (PDF -17 KB)
- Briefing information
- Slides
- Transcript (rich text format)
- Transcript (page 1 - 100, PDF) (660 KB)
- Transcript (PDF, page 101 - 200) (657 KB)
- Transcript (PDF, page 201 - 300) (659 KB)
- Transcript (PDF, page 301 - 354)
- Roster (PDF - 92 KB)
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
- Agenda (PDF - 79 KB)
- Roster - Committee (PDF - 13 KB)
- Roster - guests and consultants (PDF - 122 KB)
- Briefing information
- Slides
- Transcript (rich text format)
- Transcript (PDF - 408)
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
- Agenda (PDF - 13 KB)
- Briefing information
- Transcript (PDF - 677 KB)
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
- Agenda (PDF - 98 KB)
- Roster - Committee (PDF - 13 KB)
- Roster - guests and consultants (PDF - 64 KB)
- Briefing information
- Slides
- Transcript (WORD)
- Transcript (PDF, page 1 - 100 ) (541 KB)
- Transcript (PDF, page 101 - 200) (548 KB)
- Transcript (PDF, page 201 - 300) (5 MB)
- Transcript (PDF, page 301 - 347) (251 KB)
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
- Background
- Transcript, November 2, 1999 (rich text format)
- Transcript, November 2, 1999 (PDF, page 1 - 100) (503 KB)
- Transcript, November 2, 1999 (PDF, page 101- 200) (533 KB)
- Transcript, November 2, 1999 (PDF, page 201 - 271) (4.49 MB)
- Transcript, November 3, 1999 (rich text format)
- Transcript, November 3, 1999 (PDF, page 1 - 97) (994 KB)
- Transcript, November 3, 1999 (PDF, page 98 - 197) (432 KB)
- Transcript, November 3, 1999 (PDF, page 198 - 229) (662 KB)
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
- Meeting announcement (txt)
- Meeting announcement (PDF - 1744 KB)
- Background
- Transcript (rich text format)
- Transcript (PDF, page 1 - 100) (620 KB)
- Transcript (PDF, page 101 - 200) (534 KB)
- Transcript (PDF, page 201- 260) (367 KB)
- Transcript (PDF, page 261 - 301) (6.3 MB)
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
- Agenda (PDF - 48 KB)
- Briefing Information (PDF - 458 KB)
- Roster (PDF - 11134 KB)
- Transcript (PDF, page 1 - 100) (3.9 MB)
- Transcript (PDF, page 101 - 195) (3.7 MB)
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.
- Notice of Meeting (PDF - 20 KB)
- Briefing Information
- Background Information (PDF - 225 KB)
- Transcript (rich text format)
- Transcript PDF, pages 1 - 100) (4 MB)
- Transcript (PDF, pages 101 - 195) (3.8 MB)
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)
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)
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.