Select Publications and Public Presentations
This section includes links to the draft FDA guidance for vaginal microbicides, select presentations from public meetings, and literature publications in which FDA staff have participated. Sponsors are strongly encouraged to approach the FDA with questions specific to their product.
- Guidance for Industry: Vaginal Microbicides Development for the Prevention of HIV Infection (draft November 2012)
- Regulatory Considerations for Microbicide Development by Charu Mullick, MD (PDF - 987KB) (presented at FDA CDER Forum for International Drug Regulatory Authorities April 6, 2011)
- Microbicides: Critical Issues in Phase 2b and 3 Trials - Special Populations by Debra Birnkrant, MD (PDF - 525KB) (presented at World Health Organization (WHO) symposium M2010 Conference, Pittsburgh May 22, 2010)
- Ethical and Regulatory Considerations for the Inclusion of Adolescents in HIV Biomedical Prevention Research (PDF - 268KB). JAIDS 2010, 54:S18-21
Prior to 2009
- Recommendations for the Nonclinical Development of Topical Microbicides for Prevention of HIV Transmission: An Update, International Working Group on Vaginal Microbicides (PDF - 219KB) JAIDS 2004, 36:541-552
- Antiviral Drugs Advisory Committee Meeting: Topical Microbicides, August 20, 2003
Relevant FDA Guidance Documents
FDA CDER Guidance and Draft Guidance documents can be accessed through the Guidances web page. Select guidance documents which may be relevant to microbicide development are listed below.
- Guidance for Industry: Vaginal Microbicides: Development for the Prevention of HIV Infection (draft November 2012)
- Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (May 1998)
- Guidance for Industry: Co-development of Two or More Unmarketed Investigational Drugs for Use In Combination (draft December 2010)
- Guidance for Industry: SUPPAC-SS Nonsterile Semisolid Dosage Forms (May 1997) (PDF - 118KB)
- Guidance for Industry: Pharmacokinetics in Pregnancy - Study design, Data analysis, and Impact on Dosing and Labeling (draft November 2004)
Additional FDA Resources
The DAVP pre-IND consultation program website provides resources for drug development in general, as well as resources specific to development of products under the review jurisdiction of DAVP. Please note that pre-IND interactions should be considered as preliminary communications based on early development information, and will generally take the form of a teleconference (face-to-face meetings will be granted on a case-by-case basis). In most cases, written preliminary comments will be issued prior to the teleconference/meeting. 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.
Links to non-FDA resources
The following include links to publicly available non-FDA resources related to microbicides. Inclusion of publications or agencies/groups on this list does not imply FDA endorsement of the entity.
- White House National HIV/AIDS Strategy (released in July 2010) outlines a comprehensive HIV/AIDS plan with target goals to be achieved by 2015. One goal is reducing new HIV infections by decreasing the HIV transmission rate in the U.S. http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf
- Institute of Medicine (IOM) report on Methodological Challenges in Biomedical HIV Prevention Trials, Institute of Medicine of National Academies (released February 2008) discusses topics of trial design, monitoring, and analysis in late-stage clinical trials of biomedical interventions to prevent HIV infection. http://www.iom.edu/Activities/Research/HIVPrevTrials.aspx
- National Institute of Allergy and Infectious Diseases (NIAID) provides support for microbicide research including preclinical development of microbicides. http://www.niaid.nih.gov/topics/HIVAIDS/Research/prevention/Pages/topicalMicrobicides.aspx
- Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD and TB prevention provides HIV/AIDS estimates in United States and information about HIV transmission. www.cdc.gov/hiv
- The Joint United Nations Programme on HIV/AIDS (UNAIDS), co-sponsored in part by WHO, UNICEF and World Bank to advocate global action on HIV/AIDS, publishes periodic reports on the global burden of HIV/AIDS such as Report on Global HIV/AIDS Epidemic 2010. http://www.unaids.org/globalreport/Global_report.htm
- Microbicides Trials Network (MTN) and HIV Prevention Trials Network (HPTN) co-sponsored by National Institutes of Health are collaborative clinical trials network focusing primarily on non-vaccine interventions designed to prevent HIV transmission. http://www.mtnstopshiv.org / http://www.hptn.org/index.htm
- CDC National Prevention Information Network (NPIN) is 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. http://www.cdcnpin.org/scripts/hiv/index.asp
- WHO publication Regulatory Issues in Microbicide Development by Alan Stone (December 2010) summarizes microbicide consultations by the WHO in collaboration with other agencies in the microbicide field. http://www.who.int/reproductivehealth/publications/rtis/9789241599436/en/index.html
- ClinicalTrials.gov website is maintained by the National Institutes of Health (NIH) as a resource for locating information about clinical trials.