Getting Started with the Division of Antiviral Products Pre-IND Process
The most important first step in the Division of Antiviral Products (DAVP) Pre-IND process is to contact the DAVP Project Management Staff for a preliminary discussion regarding your product and development plans. If you are exploring product development for the treatment of a viral disease, Kyong Hyon can be contacted by telephone at (301) 796-1500 or by e-mail at firstname.lastname@example.org. You may also contact Karen Winestock by telephone at (301) 796-1500 or by email at email@example.com. Written requests regarding the DAVP Pre-IND Consultation Program can be sent to the following address
|US Postal Address|
U.S. Food & Drug Administration
U.S. Food & Drug Administration
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 request to either address above for a Pre-IND consultation/meeting, in accordance with the Letter of Instruction. Additional questions regarding the nature of this submission can be discussed with Kyong Hyon or Karen Winestock. Please submit 10 paper copies of your Pre-IND submission and clearly indicate in the cover letter and on the outside of the shipping package that the enclosed is a Pre-IND consultation request. If the meeting is granted, the DAVP Regulatory Project Manager (RPM) assigned to your submission will review your submission for completeness and contact you to provide you with a Pre-IND number and request additional information if needed.
Pre-IND consultation requests are Type B meetings and, in general, will be scheduled within 60 days of receipt of a complete request. In order to allow enough time to review your request and respond to your questions, include the information described in our Letter of Instruction with your request for a Pre-IND consultation.
Based on your meeting request and background package, DAVP determines the format of the meeting. In general, Pre-IND meetings are held as teleconferences. Face-to-face meetings will be granted on a case-by-case basis. However, effective October 1, 2012, under PDUFA V, the DAVP also has the option of providing Written Responses (WR) only in lieu of a meeting. The decision to provide WR only will be made on a case-by-case basis.
The Pre-IND submission will be distributed to our Pre-IND multidisciplinary review team for review. After the submission has been distributed, an internal review team meeting will be held to discuss your submission. DAVP’s preliminary responses to your questions will be conveyed to you prior to the teleconference/meeting. If our preliminary responses and comments are clear to you and further discussion is not required, you have the option of cancelling the meeting. If you choose to cancel the meeting, please contact the assigned RPM and submit the cancellation request to your PIND. When you cancel the meeting, DAVP’s preliminary responses will represent the official record of the meeting.
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.
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.