1. Release Notes—What's New
  2. What's New
  3. Enhancements to Oracle Argus Safety
  4. CDER E2B(R2) Similar Device Combination Products
  5. Interchange mapping updates

Interchange mapping updates

The Export Mappings for the following elements in FDA E2B(R2) 2.2 profile considers the similar device combination products:

  • DRUG [B.4]
  • DRUGCHARACTERIZATION [B.4.k.1]
  • DRUGAUTHORIZATIONNUMB [B.4.k.4.1]
  • DRUGAUTHORIZATIONCOUNTRY [B.4.k.4.2]
  • DRUGAUTHORIZATIONHOLDER [B.4.k.4.3]

Parent topic: CDER E2B(R2) Similar Device Combination Products