Configure Studies for FDA IND or Pre-ANDA reporting

IND Studies

Make sure to enter the following information for IND Studies:

IND number	Reference Type	Country	Reference Number
Specify the primary IND number associated with the study in the Clinical Reference section.	CDER-IND or CBER-IND	United States	Select the Primary IND number.
Specify one or more cross-reported IND associated with the primary IND. Here, the primary IND must be associated with the study in the Clinical Reference section.	Cross reported IND	United States	Enter the cross reported IND.

Pre-ANDA Studies

Make sure to enter the following information for Pre-ANDA Studies:

IND number	Reference Type	Country	Reference Number
Specify the primary IND number associated with the study in the Clinical Reference section.	Pre-ANDA	United States	Enter the Pre-ANDA number.