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. Such products can greatly improve the process of medication especially for patients suffering from serious chronic diseases where the ease of application and drug delivery plays a vital role in ensuring medication compliance. However as these type of products become more sophisticated, the regulatory approval pathways have come a challenge for both the regulators and the industry and has accentuated the need to develop drugs and devices collaborativelyi. In the US the Food and Drug Administration (FDA) has published several useful guidance documents to guide the industry through the regulatory maze. 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.