Configure EDI for FDA

The following table lists and describes the fields on the EDI tab to be set up for the FDA profile:

Field	IND report	Pre-ANDA report	Post Marketed report
Agency Identifier	ZZFDA_PREMKT	ZZFDA_PREMKT	ZZFDA
Secondary Agency/Department Identifier	CDER_IND or CBER_IND	CDER_IND_EXEMPT_BA_BE	CDER
File type	XML	XML	XML
Company identifier	As applicable	As applicable	As applicable
Message Profile	ICH-ICSR V3.0 MESSAGE TEMPLATE – FAERS	ICH-ICSR V3.0 MESSAGE TEMPLATE – FAERS	ICH-ICSR V3.0 MESSAGE TEMPLATE – FAERS
ACK Profile	ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE – FAERS	ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE – FAERS	ICH-ICSR V3.0 ACKNOWLEDGMENT TEMPLATE – FAERS
Suppress ACK transmission	Unchecked (Default)	Unchecked (Default)	Unchecked (Default)
Transmit ICSR Attachments	Marked	Marked	Marked
Attachment Classification	As applicable	As applicable	As applicable
Allowed attachment file size (in MB)	15 MB	15 MB	15 MB
Allowed report size (in MB)	100 MB	AS1: 10 MB AS2: 50 MB	100 MB
Incoming folder	Refer to the note below	Refer to the note below	Refer to the note below
Outgoing folder	Refer to the note below	Refer to the note below
ICSR Attachment Outgoing Folder	Not required	Not required	Not required
File Name	As required, for example: IND_########.xml	As required, for example: PREANDA_########.xml	As required, for example: NDA_########.xml
Method	E2B EDI gateway	E2B EDI gateway	E2B EDI gateway

Note:

If the common profile switch Base directory path for gateway folders is specified, then the Base directory path can be \\10.100.80.100\Gatewaysharedfolder\. The In/Out folders then need to be specified with sub folder path such as EVPM\IN, EVPM\OUT. Interchange services creates folders in the format <Base folder path>\<Abbreviated Enterprise name >\<Sub folder path>. If the folder name created by the Interchange services is not required when inserting the Abbreviated name of the Enterprise between the base directory path and the sub folder path, then the Interchange service to exclude Enterprise abbreviated name for folder creation parameter in the EDI tab of Reporting Destination code list needs to be marked.

Note:

If the Common profile Switch Base directory path for gateway folders is not specified, then In/Out folders need to be specified with an absolute path such as \\10.100.80.100\Gatewaysharedfolder\EVPM\IN. Interchange services creates folders using the folder structure provided in the Sub folder path.