Microbicides are topically applied products which may reduce the risk of HIV acquisition across vaginal or rectal mucosa. Vaginal microbicides are vaginal products which reduce HIV acquisition in women. This new FDA website brings together a variety of materials on a single page, intended to serve as a source of relevant regulatory information for investigators and industry.
The website provides access to the following important information for those involved or interested in microbicide development:
Select presentations at public meetings including
Regulatory perspectives for microbicide development including nonclinical and clinical considerations,
Critical considerations for special populations in microbicide development;
Peer-reviewed publications authored by FDA staff;
Presentations and transcript from 2003 FDA Antiviral Drugs Advisory Committee meeting for microbicides;
Links to relevant CDER guidances including a draft guidance for co-development of two unmarketed investigational agents for use in combination;
Link to CDER guidance website which lists guidance documents for drug development;
Information about communicating with FDA during drug development including the pre-investigational new drug (pre-IND) application consultation program which allows early communication prior to opening an IND;
The posted items including presentations, publications, and guidances that describe FDA thinking on the topic and are not product-specific recommendations. Sponsors are strongly encouraged to contact the FDA with questions specific to their product.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Development of Topical Microbicides and Related Information
Division of Antiviral Products (DAVP),
Office of Antimicrobial Products,
Office of New Drugs
Center for Drug Evaluation and Research (CDER)
Relevant public presentations and publications
This section includes examples of presentations from public meetings and literature publications in which FDA staff have participated. These provide illustrations of regulatory perspectives and issues relevant to microbicide development, but are not to be construed as representations of FDA policy. Sponsors are strongly encouraged to approach the FDA with questions specific to their product.
2009-2011
- Regulatory Considerations for Microbicide Development by Charu Mullick, MD (PDF - 987KB)1 (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)2 (presented at World Health Organization (WHO) symposium M2010 Conference, Pittsburgh May 22, 2010)
- Statistical Issues in Microbicide Trials by Greg Soon, PhD (PDF - 139KB)3 (presented at WHO symposium M2010, Pittsburgh May 22, 2010)
- Ethical and Regulatory Considerations for the Inclusion of Adolescents in HIV Biomedical Prevention Research (PDF - 268KB)4. 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)5 JAIDS 2004, 36:541-552
- Clinical Development of Topical Microbicides: U.S. regulatory perspective by Teresa Wu, MD PhD (PDF - 123KB)6 (presented at Microbicides 2004 conference, London)
- Antiviral Drugs Advisory Committee Meeting: Topical Microbicides, August 20, 2003
FDA Guidance Documents
FDA CDER Guidance and Draft Guidance documents can be accessed through the Guidances web page9. Select guidance documents which may be relevant to microbicide development are listed below.
- Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (May 1998)10
- Guidance for Industry: Co-development of Two or More Unmarketed Investigational Drugs for Use In Combination (draft December 2010)11
- Guidance for Industry: SUPPAC-SS Nonsterile Semisolid Dosage Forms (May 1997) (PDF - 118KB)12
Additional FDA Resources
The DAVP pre-IND consultation program website14 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.pdf15
- 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.aspx16
- 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.aspx17
- 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/hiv18
- 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.htm19
- HIV Prevention Trials Network (HPTN) co-sponsored by National Institutes of Health is a collaborative clinical trials network focusing primarily on non-vaccine interventions designed to prevent HIV transmission. http://www.hptn.org/index.htm20
- 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.asp21
- 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.html22
- ClinicalTrials.gov23 website is maintained by the National Institutes of Health (NIH) as a resource for locating information about clinical trials.
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