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  1. Guidance & Regulatory Information

Including in the ICSR Multiple Entities and/or a Specific Lot Numbers of a Constituent Part of the Combination Product

Combination Product Applicants may want to include in their Individual Case Safety Report (ICSR) information on more than one entity involved in the manufacture of the combination product and/or a specific lot of a constituent part of the combination product.  The following examples illustrate how such information may be presented when using the FAERS or eMDR reporting system:

  • FAERS scenario. NDA holder PharmComboCo is submitting an ICSR for a co-packaged combination product where the device constituent part is manufactured by DeviceCo.  PharmaComboCo has available information that the device constituent part involved in the event was from DeviceCo lot number DEVCO123 and wants to include this information in the ICSR. The lot number of the co-packaged combination product is COMBO987. 

To report information on the manufacturer and lot numbers of the device constituent part and the applicant and lot numbers of the co-packaged combination product, PharmaCo completes the following elements in the ICSR data fields for FAERS:

Type of Information Data Element DTD Descriptor Element Value
Combination Product Applicant B.4.k.4.3 <drugauthorizationholder>  PharmaComboCo
Device Constituent Part Manufacturer B.4.k.20.FDA.4a <manufacturername> DeviceCo
Lot/batch number of the combination product B.4.k.3 <drugbatchnumb>  COMBO987
Lot/batch number of the device constituent B.4.k.20.FDA.16  <devicelotnumber>  DEVCO123
  • eMDR scenario.  PMA holder ComboMedCo is submitting an ICSR for a single-entity combination product where the lot of the combination product is lot 123, manufactured at a facility operated by ContractCo rather than by ComboMedCo.  ComboMedCo has available information that lot 098 of the drug constituent part was used to manufacture the combination product and wants to include this information in the ICSR. 

To report information on the applicant, contract manufacturer, and lot numbers of both the single-entity combination product  and the drug constituent part, ComboMedCo completes the following elements in the ICSR data fields for eMDR:

Type of Information Form 3500A Identifier  eMDR Preferred Element Value
Combination Product Applicant Manufacturer Name [Box D.3] Manufacture Name  ComboMedCo
Combination Product Manufacturer Contact Office
[Box G.1] 		 Contact Office   ContractCo
Lot/batch number of the combination product  Lot # [Box D.4]  Lot #  123
Lot/batch number of the drug constituent part Lot # [Box C.1]  Lot # [under Suspect Products] 098

 

 

 

 

 
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