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, Victoria Tyson for a preliminary discussion regarding your product and development plans. Victoria Tyson can be contacted by e-mail at victoria.tyson@fda.hhs.gov or by phone at (301) 796-1500. You may also contact Karen Winestock at karen.winestock@fda.hhs.gov or (301) 796-1500. Written requests regarding the DAVP Pre-IND Consultation Program can be sent to the following address:
 

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.