Replies to post #40461 on NanoViricides Inc. (NNVC)

[BonelessCat]

Pre-IND is a stage. One files for a meeting, not a phone call, and the FDA agrees, formally. The meeting takes place and the FDA determines what final testing it wants to see (if any) prior to filing the INDA. The filer gets the answers in writing. The period between the pre-IND meeting and the INDA filing is the pre-IND stage. The pre-IND is voluntary, but most everyone planning on filing an INDA takes the meeting. The risk of not taking that meeting is getting sandbagged by an FDA comment following the INDA. The IND is automatically effective after 30 days provided the FDA has no questions. Questions can delay an IND for up to 2 years.

[mkendra]

CDER offers a Pre-Investigational New Drug Application (IND) Consultation Program to foster early communications between sponsors and new drug review divisions in order to provide guidance on the data necessary to warrant IND submission.

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/Overview/UCM166356.pdf