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
additional resources
and suggested links for Topical Microbicide Development.
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
anthony.decicco@fda.hhs.gov.
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Date created: November 17, 2004, updated December 13, 2005 |