Combination Products – Basic Principles: Regulatory Framework, Current Issues and Status

  • Background: combination products, how they work, how are they used; history, development analysis of relevant FDA laws, regulations, guidance, policy, organization; contrast to EU approach
  • Drug delivery systems, medicated devices, companion diagnostics, drug/biologic combination products
  • Product development: preclinical, clinical, CMC/device; collaborative development; strategy
  • Marketing applications and labeling: format and content; CTD
  • Quality Systems
  • Safety Reporting
  • Post-approval change reporting
  • Compendial requirements
  • Other pre- and post-approval issues
  • Case studies