Recommended 15 Day Reporting Rule For Combination Products - Serious and Unexpected
(Doc ID 2850398.1)
Last updated on JULY 26, 2022
Applies to:Oracle Argus Safety - Version 8.2.2 and later
Information in this document applies to any platform.
In the below documentation it mentions a recommended 15-day reporting rule setting as Event Serious = Yes:
Oracle Argus Safety CDER E2B(R2) Combination Product Best Practices" document published in Oracle Argus 8.2.2 Release Notes (Note 2686482.1).
However in the current FDA provided regulations
'Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff' (Refer page#12 and Appendix 2) it states that:
'Combination Product Applicants must submit Fifteen-day reports for:
• "adverse experiences” that are both “serious" and "unexpected"
However the Argus 'CDER E2B(R2) Combination Product Best Practices' says only that the event is equal to serious.
Hence there is a gap between Oracle Best practice for 15 days report versus FDA regulations which include for “Unexpected”
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