1. CDER E2B(R2) Combination Product Best Practices
  2. Co-packaged Combination Product Case Processing

11 Co-packaged Combination Product Case Processing

These are the steps for creating/processing cases with Co-packaged Combination Products:
  1. Book-in a Case with information received as per Source documents.
  2. If the Suspect Product involved is a Combination Product, ensure the Primary mode of action (PMOA) product is selected first using the Product browser and the drug data is entered.
  3. Add the Constituent Device Product using the Product browser.
  4. Enter the Device data in the Constituent Product.
  5. Select Combination Product in the General > Case Classification field.
  6. Save the case and ensure all the mandatory data required for CDER submission is entered.
  7. Perform Auto-scheduling and the system schedules an E2B report for the PMOA Product to CDER agency using the FDA 2.2 DTD Profile.
  8. Click Draft link to preview the report in XML view.
  9. The <combinationproductreport> element is populated with value 1 indicating ICSR contains Combination Product.
  10. The Device data is embedded within the <drug> block pertaining to the Primary mode of action product as per the example provided in the Single Entity Combination section.