Share

Print

Comment Letters

• RE: Docket No. FDA–2011–D–0868 - Draft Guidance for Industry on Responding to Unsolicited Requests for Off-­Label Information About Prescription Drugs and Medical Devices (Draft Guidance) Mar 26, 2012 ...and Docket No. FDA–2011–N–0912 -­ Communications and Activities Related to Off-­ Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed; Request for Information and Comments    more...  
• Re: Request for Priority Review – Supplemental NDA submission by Gilead Sciences, Inc. requesting approval of a labeling change to include HIV prevention indication use for emtricitabine; tenofovir disoproxil fumarate fixed dose combination Jan 25, 2012 We write as a coalition of 25 leading HIV/AIDS and health organizations to request that FDA grant priority review of a supplemental New Drug Application (sNDA) for the approval of emtricitabine/tenofovir disoproxil fumarate (Truvada) fixed dose combination for pre-exposure prophylaxis (PrEP) to...    more...  
• RE: Request for Information: Public Access to Peer-­‐Reviewed Scholarly Publications Resulting From Federally Funded Research 76 Fed. Reg. 68518, November 3, 2011 Jan 12, 2012 Patients, academics, researchers and advocates deserve free, timely, and complete access to these articles. The NIH policy began to restore balance to this system. The OSTP can now build upon the NIH policy to fuel innovation and improve health outcomes.    more...  
• RE: Request for Information: Public Access to Digital Data Resulting From Federally Funded Research 76 Fed. Reg. 70176, November 10, 2011. Jan 12, 2012 The public's need to know the complete results of research it pays for is clear and immediate. Immediate access to public or consortia managed access to data that has undergone quality assurance is justified by the benefits which accrue from increasing comparability of results, delivery of...    more...  
• RE: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators Oct 26, 2011 Jerry Menikoff, M.D., J.D. 
Office of Human Research Protections (OHRP) 1101 Wootton Parkway, Suite 200 
Rockville, MD 20852 RE: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators – Advance Notice...    more...  
• PEPFAR Technical Guidance: Prevention for Men Who Have Sex With Men1 (MSM Technical Guidance)- PEPFAR Science Advisory Board Meeting Aug 1, 2011 Office of the Global AIDS Coordinator SA-29, 2nd floor 2201 C. Street NW Washington, DC 20522-2920 PEPFAR Scientific Advisory Board (SAB) Attn: Tiffany Peoples - PeoplesTN2@state.gov Paul Bouey - BoueyPD@state.gov Nancy Padian - npadian@globalhealth.ucsf.edu...    more...  
• Comments on Concept paper on the guidance on the non-clinical and clinical development of medicinal products for HIV prevention including oral and topical PrEP (EMA/86004/2011) Apr 30, 2011 European Medicines Agency 7 Westferry Circus London E14 AHB United Kingdom Re: Concept paper on the guidance on the non-clinical and clinical development of medicinal products for HIV prevention including oral and topical PrEP (EMA/86004/2011) To the European Medicines Agency:...    more...  
• RE: Request for Comments on Human Subjects Protections in Scientific Studies 76 Fed. Reg. 11482, March 2, 2011 Apr 27, 2011 Public Commentary The Presidential Commission for the Study of Bioethical Issues (Commission) 1425 New York Ave., NW, Suite C–100 Washington, DC 20005 info@bioethics.gov RE: Request for Comments on Human Subjects Protections in Scientific Studies 76 Fed. Reg. 11482, March 2,...    more...  
• Division of Dockets Management [HFA-305] Food and Drug Administration 5630 Fishers Lane Room 1061 Dec 28, 2010 Division of Dockets Management [HFA-305] Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20993 RE: [Docket No. FDA-2010-N-0437] –Development and Distribution of Patient Medication Information for Prescription Drugs To the Food and Drug Administration AVAC, a...    more...  
• Request for Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System 75 Fed. Reg. 57261 Sep 20, 2010 HumanitarianProgram@uspto.gov Mail Stop Comments Patents, Commissioner for Patents US Patent and Trademark Office (USPTO) P.O. Box 1450, Alexandria, VA 22313–1450 Attention: Joni Y. Chang. RE: Request for Comments on Incentivizing Humanitarian Technologies and Licensing Through...    more...  
• OSTP Comments on Public Access Jan 21, 2010 Office of Science and Technology Policy Executive Office of the President 725 17th Street Room 5228 Washington, DC 20502 Re: Public Access for Publically Funded Research Dear OSTP: Thank you for giving us the opportunity to provide comments to OSTP as it considers the policy of...    more...  
• Guidance for Industry: Tropical Disease Priority Vouchers, Docket No. FDA 2008-N-0567. Feb 6, 2009 The AIDS Vaccine Advocacy Coalition (AVAC), the Alliance for Microbicide Development (AMD), the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), the International AIDS Vaccine Initiative (IAVI) and the Global Campaign for Microbicide Development (GCM) are pleased to respond to the FDA's...    more...  
• Proposed Rule - Issuance of a Visa and Authorization for Temporary Admission Into the United States for Certain Nonimmigrant Aliens Infected With HIV (HIV Waiver Application Proposal) Dec 6, 2007 Please accept these comments requesting DHS to withdraw the impractical and unfair HIV Waiver Application Proposal cited above. These comments ask DHS to prepare alternative rules, grounded in supportable and compassionate public health policy, in keeping with internationally accepted principles...    more...  
• Intergovernmental Working Group on Public Health, Innovation & Intellectual Property Nov 13, 2006 The AIDS Vaccine Advocacy Coalition (AVAC) welcomes this opportunity to comment on the Report of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (the "Report"). AVAC is a volunteer and nonprofit public interest organization dedicated to accelerating...    more...  
• FIC Strategic Plan to Guide Center Activities in the Next 5 years. Nov 12, 2006 Thank you for the opportunity announced on your website to provide suggestions to help the FIC build its next strategic plan for reducing disparities in global health. We are nongovernmental patient advocates and representatives of study populations, individually and in HIV/AIDS organizations. We...    more...  
• Guidance for Industry - Development of Preventive HIV Vaccines for Use in Pediatric Populations (Guidance) Oct 27, 2006 Thank you for the opportunity to provide comments regarding the FDA's Guidance for development of preventive HIV vaccines for use in pediatric populations. These comments are submitted on behalf of the AIDS Vaccine Advocacy Coalition (AVAC). AVAC is a volunteer and nonprofit public interest...    more...  
• Prompt Action to Revise the National Institutes of Health (NIH) Public Access Policy to Ensure The American Public Has Free and Timely Access to the Results of Research Funded by our Tax Dollars May 22, 2006 We are writing to urge that you take prompt action to revise the National Institutes of Health (NIH) Public Access Policy to ensure the American public has free and timely access to the results of research funded by our tax dollars. AVAC is a volunteer and nonprofit public interest organization...    more...  
• Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others (Guidance) Jan 13, 2006 The AIDS Vaccine Advocacy Coalition (AVAC) welcomes this opportunity to comment on OHRP's Guidance cited above. AVAC is a volunteer and nonprofit public interest organization dedicated to accelerating ethical research and global delivery of vaccines to fight the AIDS pandemic. AVAC itself or in...    more...  
• Advanced Market Commitments -- Consultation 2005 Jan 10, 2006 The AIDS Vaccine Advocacy Coalition (AVAC) welcomes this opportunity to comment on DFID's Consultation Document on Advanced Market Commitments (AMCs). AVAC is a volunteer and nonprofit public interest organization dedicated to accelerating ethical research and global delivery of vaccines to...    more...  
• RE: Draft International Guidelines for Ethical Review of Epidemiological Studies. Oct 31, 2005 The AIDS Vaccine Advocacy Coalition (AVAC) welcomes this opportunity to comment on the CIOMS draft ES Guidelines. AVAC is a not-for-profit public interest organization dedicated to accelerating ethical research and global delivery of vaccines to fight the AIDS pandemic. Among other activities,...    more...  
• Draft Manuscript for "Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation". WHO 2005 Sep 22, 2005 The AIDS Vaccine Advocacy Coalition (AVAC) welcomes this opportunity to comment on the WHO's Draft Manuscript: "Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation" (Draft). AVAC is a volunteer and nonprofit public interest organization dedicated to ethical research...    more...  
• Comments on FDA's Draft Guidance for Industry on Using a Centralized Institutional Review Boards Process in Multicenter Clinical Trials (IRB Guidance) May 26, 2005 Thank you for this opportunity to comment on the FDA's IRB Guidance. We are current or former volunteers, representatives of participants in clinical trial research, on authorized Community Advisory Board (CABs) which review government sponsored clinical trials testing vaccines to fight...    more...  
• Re: Proposed Criteria for Determinations of Equivalent Protection (EP Criteria Proposal) May 20, 2005 The AIDS Vaccine Advocacy Coalition (AVAC) welcomes this opportunity to comment on the OHRP's EP Criteria Proposal and the associated Report of the Equivalent Protections Working Group. AVAC is a volunteer and nonprofit public interest organization dedicated to ethical research and...    more...  
• Comments on FDA's Draft Guidance for Industry: Considerations for Plasmid DNA Apr 29, 2005 The AIDS Vaccine Advocacy Coalition (AVAC) appreciates this opportunity to comment on the FDA's draft DNA Vaccine Guidance. AVAC is a volunteer and nonprofit public interest organization dedicated to ethical research and accelerating global delivery of vaccines to fight the AIDS pandemic. To...    more...  
• Comments on FDA's Hearing and Workshop - Reporting of Adverse Events to Institutional Review Boards (IRB) Apr 20, 2005 Thank you for this opportunity to comment on the FDA's IRB adverse event reporting hearing and workshop (IRB workshop). We are current or former volunteers, representatives of participants in human subject research, on authorized Community Advisory Board (CABs) which review government sponsored...    more...  
• Comments on FDA's Hearing and Workshop - Reporting of Adverse Events to Institutional Review Boards (IRB) Apr 17, 2005 The AIDS Vaccine Advocacy Coalition (AVAC) appreciates this opportunity to comment on the FDA's IRB adverse event reporting hearing and workshop (IRB workshop). AVAC is a volunteer and nonprofit public interest organization dedicated to ethical research and global delivery of vaccines to fight...    more...  
• Re: Enhanced Public Access to National Institutes of Health (NIH) Research Information -- (Notice) 69 Fed. Reg. 56074, September 17, 2004 Nov 1, 2004 The AIDS Vaccine Advocacy Coalition (AVAC) appreciates this opportunity to supplement our previous comments to NIH dated August 6 and 25, 2004 and now in support of the formal published concept dated September 17, 2004 to increase public access to NIH health related research information. Copies...    more...  
• RE: Docket No. 2004N-0018; Human Subject Protection -- Foreign Clinical Studies Not Conducted Under an Investigational New Drug (IND) Application Sep 7, 2004 The AIDS Vaccine Advocacy Coalition (AVAC) is a volunteer and nonprofit organization dedicated to ethical research and global delivery of AIDS vaccines. We are pleased to submit these comments regarding FDA's proposed rule on acceptance of foreign clinical studies not conducted under an IND as...    more...  
• RE: Open Access Publication of Scientific Research -- FY 2005 Appropriations Aug 6, 2004 Our organizations are volunteer and nonprofit HIV/AIDS treatment, vaccine, and prevention advocacy groups with a long history of community participation in all aspects of government and privately sponsored research to fight the AIDS pandemic. In that capacity, we support at July 16, 2004 House...    more...  
• Re: Critical Path Initiative, Docket No. 2004-N-0181; 69 Fed. Reg. 21839, April 22, 2004 Jul 29, 2004 The AIDS Vaccine Advocacy Coalition (AVAC) is pleased to submit these comments to identify pressing scientific or technical hurdles, along with solutions, in medical product development as part of FDA's Critical Path Initiative (Initiative). AVAC is a volunteer and nonprofit public interest...    more...  
• International Conference on Harmonisation: Draft Guidance on E2E Pharmcovigilance Planning ( May 14, 2004 Thank you for providing an opportunity for consumer representatives and patient advocates to comment on the ICH-E2E draft guidance that FDA and others would use to plan risk identification activities during postmarketing periods for drugs or biologics. The importance of followup risk...    more...  
• Innovation or Stagnation? -- Challenge and Opportunity on the Critical Path to New Medical Products ( Apr 13, 2004 Thank you for the opportunity to comment to the FDA and the Science Board as the Agency launches the program described in the Critical Path White Paper (or "Proposal" -- http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html). We are nonprofit and volunteer patient advocates working in...    more...  
• Comments on FDA's Proposed Rule -- Safety Reporting Requirements for Human Drug and Biological Products Oct 10, 2003 425 Market Street, 32nd Floor San Francisco, CA 94105 Writer's Direct Contact 415/268-7469 RReinhar@mofo.com Via E-Mail FDADockets@oc.fda.gov And hardcopy followup by U.S. Mail Dockets Management Branch (HFA-305) Food and Drug Administration ("FDA") 5630 Fishers Lane, rm. 1061...    more...  
• Comments on Department of Health and Human Services ("DHHS") Proposed Standards for Privacy of Individually Identifiable Health Information Apr 24, 2002 The organization and the individual joint signators to this letter appreciate the opportunity to submit comments on the Proposed Privacy Rule. Individual signators have provided names and, in some cases, also the names of affiliates we work with to inform you about our backgrounds, but we do not...    more...