Configure expedited rules

Make sure to enter the following information in the reporting rules created for IND, Pre-ANDA and Spontaneous IND Study cases in addition to other reporting criteria that are configured in the expedited rules.

The following rules are based on the ICHICSR/E2B message type and report format. Except for the CDER-30 Day WORLD rule, all rules apply exclusively to the United States.

Rule	Reporting Destination	License Type	Time Frame	Condition
CDER-15 Day	ZZFDA/CDER	Marketed Drug	15	Serious (Event) = Yes
CDER-60 Day	ZZFDA/CDER	Marketed Drug	60	Case Serious = No; Any other condition as per your company's business process
CDER-5 Day	ZZFDA/CDER	Marketed Drug (for Combination Products)	5	Criteria using Advance conditions Remedial Action exists Case Classification = Combination Product any other condition as per your company’s business process
CDER-30 Day	ZZFDA/CDER	Marketed Drug (for Combination Products)	30	Case Serious = No Criteria using Advance conditions Malfunction = Yes Case Classification = Combination Product Any other condition as per your company’s business process
CDER-30 Day WORLD	ZZFDA/CDER	Marketed Drug (for Combination Products)	30	Case Serious = No Criteria using Advance conditions: Case Classification = Combination Product Malfunction = Yes Product type = Treatment/Other Drug not administered = Yes Similar Device = Yes
IND - CDER-15 Day IND-CBER-15 Day	ZZFDA_PREMKT/CDER_IND ZZFDA_PREMKT/CBER_IND	Investigational drug	15	Event Serious =Yes and Listedness (Event) = No Study Reference Type=CDER-IND/ CBER-IND Any other condition as per your company’s business process
IND - CDER-7 Day IND - CBER-7 Day	ZZFDA_PREMKT/CDER_IND ZZFDA_PREMKT/CBER_IND	Investigational drug	7	Event Serious =Yes and Listedness (Event) = No S/UL/Fatal/LT = Yes Study Reference Type=CDER-IND/ CBER-IND Any other condition as per your company’s business process
Pre-ANDA	ZZFDA_PREMKT/CDER_IND_EXEMPT_BA_BE	Investigational drug	15	Event Serious =Yes and Listedness (Event) = No Study Reference Type=Pre-ANDA Any other condition as per your company’s business process
IND for Post Marketed Cases	ZZFDA_PREMKT/CDER_IND or CBER_IND	Investigational drug	15 or 7	Event Serious =Yes and Listedness (Event) = No Study Reference Type=Ignore Any other condition as per your company’s business process

Transitioning from MedWatch to E2B(R3)

If you are transitioning from MedWatch format to E2B(R3) for IND reporting to FDA, then it is recommended the existing rules used for reporting to FDA by updating the report form to E2B, and configure additional information required as specified above.

When transitioning, the first E2B(R3) report generated from a case in place of the MedWatch report will be displayed as an initial report.

If transitioning from E2B(R2) to E2B(R3), then the follow-up numbering will continue.

If you decide to create a new agency, any case updates are transmitted as an initial report to the new agency.

If you are not transitioning from the MedWatch format to E2B(R3) for FDA reporting, then it is recommended to modify the Reporting Destination > Message Profile used for MedWatch reporting to FDA MEDWATCH 3500A DRUG TEMPLATE.

If the profile in the agency settings is changed to the FDA MEDWATCH 3500A DRUG TEMPLATE or the E2B(R3) profile ICH-ICSR V3.0 MESSAGE TEMPLATE - FAERS, then it is not recommended to switch back to the MedWatch paper reporting format.