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Division of Antiviral Products (DAVP)
Getting Started with the Pre-IND Process
The most important first step in the DAVP Pre-IND process is to make contact with the DAVP Project Manager, Tanima Sinha for a preliminary discussion regarding your product and development plans. Tanima Sinha can be contacted by e-mail at tanima.sinha@fda.hhs.gov or by phone at (301) 796-0812. You may also contact Karen Winestock at karen.winestock@fda.hhs.gov or (301) 796-0834. Written requests regarding the DAVP Pre-IND Consultation Program can be sent to the following address:
| US Postal Address |
Overnight Address |
U.S. Food & Drug
Administration
Office of Antimicrobial Products
Division of Antiviral Products
Attention: Pre-IND Consultation Program
10903 New Hampshire Avenue
Building #22, Room 6371
Silver Spring, MD, 20993 |
U.S. Food & Drug Administration
Division of Antiviral Drug Products
Pre-IND Consultation Program
Attn: Tanima Sinha, Project Manager
Room: 6371
10903 New Hampshire Avenue
Silver Spring, MD, 20903 |
Next, obtain and review the Letter of
Instruction which discusses the content and format of a Pre-IND
submission.
If appropriate, prepare and send your Pre-IND submission for review,
in accordance with the letter of instruction, to either address
above. Additional questions regarding the nature of this submission
can be discussed with Tony DeCicco. Please supply 10 copies of
your Pre-IND submission and clearly indicate in your cover letter
and on the outside of the shipping package that the enclosed is a
Pre-IND submission. You will receive a telephone call from the
assigned DAVP Pre-IND project manager in acknowledgement of your
submission and to further discuss the review timeline for your
submission. Please note that the addresses listed above are for
DAVP Pre-IND submissions only. Initial IND submissions should
continue to be addressed as described in
21 CFR 312.140.
Review Timeline
After your Pre-IND submission is received by DAVP, the Pre-IND
administrative staff will review your document for completeness. You
will be contacted if additional information is necessary to
facilitate our review. If no additional information is needed or
when all of the additional information has been provided, your Pre-IND
submission will be distributed to our Pre-IND multidisciplinary
review team for review. Approximately three (3) weeks after the
submission has been distributed, an internal review team meeting
will be held to allow the reviewers, as a group, to discuss your
submission. Then, approximately two (2) weeks after the internal
meeting, a Pre-IND letter containing comments and suggestions to
support an IND submission will be conveyed to you. In general, a
Pre-IND review cycle will take approximately six (6) weeks.
Follow-up telephone conferences and/or face-to-face meetings can be
scheduled as necessary.
Additional resources and references are available at
Office of Antimicrobial
Products (OAP) Pre-IND Additional
Resources/References.
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.
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Date created: September 8, 2004, updated August 27, 2008 |
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