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 (i.e, drug, monoclonal antibody, therapeutic protein) development for the treatment of a viral infection, Nina Mani, PhD, MPH can be contacted by telephone at (301) 796-1500 or by e-mail at Nina.Mani@fda.hhs.gov. You may also contact Karen Winestock by telephone at (301) 796-1500 or by email at Karen.Winestock@fda.hhs.gov

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 below 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 Nina Mani or Karen Winestock. If you are submitting an application using the electronic common technical document format (eCTD), please review http://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm163184.htm for instructions on obtaining a preassigned application number. If you are submitting a paper submission, please submit three copies to the official submission address below and 10 paper copies to the desk copy address below. You should ensure that your Pre-IND submission clearly indicates 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.

Review Timeline

Pre-IND meeting requests are Type B meetings. Based on your meeting request, DAVP determines the format of the meeting. In general, Pre-IND meetings are granted as Written Responses only in lieu of a meeting. However, a teleconference or face-to-face meeting will be granted on a case-by-case basis. If a meeting or teleconference is granted, it will be scheduled within 60 days of receipt of the meeting request. If a Written Responses Only meeting is granted, you will receive our written response within 60 days of receipt of the meeting request. Your briefing package is due 30 days prior to the meeting/written response date. Please see the Guidance for Industry document entitled, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” for additional information. If a meeting or teleconference is scheduled, DAVP’s preliminary responses to your questions will be conveyed to you prior to the teleconference/meeting date. 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.

Related Information

• Division of Anti-Viral Products (DAVP) Pre-IND Letter of Instruction
• Additional Resources Regarding Drug Development
• Code of Federal Regulations Title 21

Additional Information

• Development of Vaginal Microbicides and Related Information
• Pre-IND Consultation Program Glossary