Configure Studies for FDA IND or Pre-ANDA reporting

IND Studies

Make sure to enter the clinical reference for IND studies, including the primary IND number associated with the study. Optionally, you can also add the cross-reported IND number, if applicable.

Reference Type	Country	Reference Number
CDER-IND or CBER-IND	United States	Select the Primary IND number.
Cross reported IND	United States	Enter the cross reported IND.

Pre-ANDA Studies

Make sure to enter the clinical reference for Pre-ANDA studies and include the primary IND number associated with the study.

Reference Type	Country	Reference Number
Pre-ANDA	United States	Enter the Pre-ANDA number.

Note:

Cross-reported IND numbers [FDA C.5.6.r] for IND reports are auto-populated by Interchange based on the product's license configuration. Refer to the FAERS mappings in the E2B R3 mapping document for additional details. Additionally, manually configured INDs in the study will also be transmitted.