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Additional Resources Regarding Drug Development of Topical Microbicides

FDA Presentations from Symposia and Meetings

  • August 20, 2003, Antiviral Drugs Advisory Committee Meeting (Bethesda, MD)

  • Clinical Development of Topical Microbicides: U.S. Regulatory Perspective, Teresa C. Wu, M.D., Ph.D., FDA, March 28-31, 2004, Microbicides 2004 Meeting, London, UK. [PDF] 

General Documents:

  • FDA Guidance Documents Guidance documents available from the FDA Center for Drug Evaluation and Research (CDER) can be accessed through the Guidance web page, via contacting the CDER Drug Information Branch at 301-827-4573, or by accessing the Fax-on-Demand system at 800-342-2722 or 301-827-0577.

  • Guidance for Industry: SUPPAC-SS Nonsterile Semisolid Dosage Forms" (May 1997) [PDF]

  • Federal Register:

    • Vaginal Contraceptive Drug Products for Over-the-Counter Human Use; Establishment of Monograph; Notice of Proposed Rulemaking (December 12, 1980)

    • Vaginal Contraceptive Drug Products for Over-the-Counter Human Use; Notice of Proposed Rulemaking (February 3, 1995) [TEXT]

Other Documents

Additional Resources

  • For a list of resources regarding drug development in general (including funding and education) and resources specific to the development of products under the review jurisdiction of ODEIV, please refer to the ODEIV Pre-IND Consultation Program web site under Additional Resources.

  • The Joint United Nations Programme on HIV/AIDS (UNAIDS): A program co-sponsored in part by UNICEF, WHO, and the World Bank, to advocate global action on HIV/AIDS by attempting to lead, strengthen, and support efforts to prevent the transmission of HIV. UNAIDS may be contacted at their site on the World Wide Web at http://www.unaids.org.

  • International Working Group on Microbicides (IWGM): The IWGM was formed in November 1993 at a WHO meeting in Geneva, Switzerland. The IWGM’s goal is to facilitate the development, production, and distribution of vaginal microbicides for the prevention of transmission of HIV and other STDs. The IWGM may be contacted through the UNAIDS at: International Working Group on Vaginal Microbicides, c/o UNAIDS, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland

  • AIDS Clinical Trials Information Service (ACTIS): The ACTIS is a cooperative effort by the Centers for Disease Control (CDC), the National Institute of Allergy and Infectious Diseases (NIAID), the National Library of Medicine (NLM), and the Food and Drug Administration (FDA). Made possible by the Health Omnibus Programs Extension (HOPE) Act of November 1988, the ACTIS makes available information about AIDS/HIV-related clinical trials being conducted all over the United States. The ACTIS may be reached at 1-800-874-2572 (1-800-TRIALS A) or on the World Wide Web at http://www.ACTIS.org. (External Site)

  • HIV/AIDS Treatment Information Service (ATIS): The ATIS provides information about federally approved treatment guidelines for HIV and AIDS, as well as information regarding subjects of general interest related to HIV and AIDS. The ATIS may be reached at 1-800-448-0440.

  • National Institute of Allergy & Infectious Diseases (NIAID)

  • National Institutes of Health, National Center for Complementary and Alternative Medicine (NCCAM): National Center for Complementary and Alternative Medicine (NCCAM) was mandated by Congress in 1991 and permanently established within the Office of the Director of the National Institutes of Health. The NCCAM’s mission is to encourage and support the investigation of alternative medical (AM) practices, with the ultimate goal of integrating validated AM practices into health and medical care [NIH Guide, Vol. 23, Number 15, April 15, 1994].

  •  National Center for HIV, STD and TB Prevention - Divisions of HIV/AIDS Prevention

  • CDC National Prevention Information Network (NPIN): A CDC-maintained database which includes private and government funding opportunities regarding HIV/AIDS, STD, and TB education, prevention, social/support services, and information dissemination. You can reach the NPIN at 1-800-458-5231, Monday - Friday, 9:00am -6:00pm Eastern Time (ET).

Note: Pre-IND interactions should be considered as preliminary communications based on early development information, and will generally take the form of written comments that may be supplemented by teleconferences or meetings as needed and appropriate. Additions or modifications to these communications may arise as additional information becomes available, during follow-up pre-IND interactions or when an IND is established.

    
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