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  7. Regulatory Information for INDs
  8. Pre-INDs for Topical Microbicides
  1. Regulatory Information for INDs

Pre-INDs for Topical Microbicides

Products to Prevent Vaginal Transmission of Sexually Transmitted Diseases


How Do I Obtain Further Information Regarding Pre-IND Submissions for Topical Microbicide Antiviral Products?

For Pre-IND submissions and/or guidance, the working group functions closely with the Division of Antiviral Products (DAVP) Pre-IND Consultation Program; general information regarding Pre-IND submissions, including submissions for Topical Microbicide Products and points of contact, can be found at the DAVP’s Getting Started Page of the DAVP Pre-IND Consultation Program, and at Development of Topical Microbicides and Related Information.


Additional Information and Resources Regarding Pre-IND Drug Development for Topical Microbicide Products:

For information regarding both general and specific regulatory/scientific areas, additional resources and suggested links are available.

Note: DAVP 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.

Please direct any comments regarding DAVP Pre-IND/Topical Microbicide Web Pages to kyong.hyon@fda.hhs.gov.



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