January 2006
The FDA will assist investigators who need consultation regarding when to submit an IND application before starting a research study. Most commonly this question arises when an investigator wants to use an FDA approved product off-label.
Pre-IND Consultation Program: 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. The review divisions are organized generally along therapeutic class. Investigators may identify and contact the appropriate person using the designated Pre-IND Consultation List at: http://www.fda.gov/cder/ode4/preind/Pre-INDConsultationList.pdf. The FDA division you contact may or may not be able to assess your IND request over the telephone, and will inform you as to what information will be required. The FDA division office may determine that the IND is exempt, in which case the investigator will receive a letter to that effect. This letter may be uploaded into the eIRB application going to the JHM IRB. If, on the other hand, the FDA determines that an IND is required, it already will have the paperwork necessary for the IND submission, and can proceed directly to review it to determine whether an IND can be granted for the protocol. For general IND information, please refer to the FDA’s Investigational New Drug (IND) Application Process site at http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm . |
