Introduction to Drug-Device Combination Products Regulation

Drug-device combination products present novel product developments and allow for safer and more effective treatments and individualized therapy. This book looks at the regulatory approval challenges and guidance’s available to help people working in the combination product regulatory environment, address all relevant regulatory requirements while avoiding redundancies.
Topics covered include definitions is different regions including the US, the EU, Australia and Japan, the number and type of applications and the choice of the lead center for evaluation (drug or device), the type of documentation required and development considerations. The quality requirements for different types of combination products is analyzed including single entity products, combination products which are co-packaged and combination products sold separately or cross referenced. Other topics covered include post-market issues related to both cross labeled products sold separately and single entity and co-packaged products and Life-Cycle-Management issues.