13 FAQ
What type of product configuration is recommended for Combination Products?
If the PMOA Product is a single device constituent, then the product can be configured as per the steps suggested in the single entity combination products.
However, if there is a requirement to perform assessment of vaccine and devices separately in the case then it is recommended to configure the PMOA and device constituents under different products.
If the PMOA Product has a multiple device constituents, then the product can be configured as per steps suggested in the co-packaged combination products.
In the flexible COMBO_PRODUCT_RELATI ONSHIP codelist, is it required to enter Product Name or Trade Name for PMOA and Constituent Products?
It is required to specify the Product Name and not the Trade Name.
Does the Combination Product solution provided byOracle Argus Safety allow configuration of Combination Product that comprises for multiple device constituents?
Yes, if the Combination Product comprises of multiple device constituents, then it is required to create separate entries for each of the device constituent in COMBO_PRODUCT_RELATI ONSHIP codelist with the same PMOA Product.
For which type of Combination Products is the flexible codelist configuration required?
- Company Drug / Biologic (PMOA Product) and Company Device (Constituent Product)
- Company Vaccine (PMOA Product) and Company Device (Constituent Product)
If the Device is a PMOA Product, is it required to configure the combination products in the flexible codelist?
For the products having device as a PMOA Product, eMDRs must be submitted. eMDRs do not require configuration of flexible recategorization codelists for combination products, as eMDR does not embed the constituent product data within the PMOA product block.
Is MAH required to report cases that contain combination products that include a non-company product as PMOA?
MAH is not required to report to the FDA on cases that contain combination products that include a non-company product as PMOA.
Do the entries populated in the CASE_PMOA_CONS_RELATI ON table for a case get copied on performing Case Copy?
No, Case Copy does not copy the data from the CASE_PMOA_CONS_RELATI ON table. The data present in this table is neither printed in Case Form Print, nor is it audit logged.
If a Case having drug and device data was submitted as eVAERS to FDA in prior versions of Oracle Argus Safety and now if there is a follow-up data is received and requires to be processed as Combination Product, what needs to be done from the data entry perspective?
- Case Classification needs to be set to Combination Product.
- Ensure that the appropriate device information is entered for the device constituents.
- Generate the eVAERS report draft to the CBER_VAERS agency to check if case qualifies to be Combination Product Case.
If a PMOA Product has multiple device constituents associated, is it required to enter all the device constituents in the case in order to recognize the product as Combination Product?
If the case has PMOA Product along with at least one device constituent present, then it is considered as a Combination Product. The system does not expect all device constituents to be entered in the case.
If a foreign case (Non-US) has a combination product having equivalent US licensed combination products, will the system be able to determine that the case qualifies for combination product reporting in US?
Yes, the system evaluates the products within the case and compares all licenses associated with the product with the entries in the flexible codelist and determines if it is a combination product or not.