Configure the EDI and Report tab for FDA

The following table lists and describes the fields on the EDI and Report tabs 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 Additional Information chapter	Refer to the Additional Information chapter	Refer to the Additional Information chapter
Outgoing folder	Refer to the Additional Information chapter	Refer to the Additional Information chapter	Refer to the Additional Information chapter
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
Apply EMA Special Rules	Marked	Marked	Marked

Note:

You can check the Apply EMA Special Rules checkbox to apply EMA special instruction rules for cases that have at least one Reporter’s Country that belongs to the European Union.