Drug-Led Combination Products - Submission Guidance and Contents

Drug-led combination products play an increasingly important role in the delivery of medicines. These devices can increase the therapeutic benefit of medicines, increase patience convenience, and lower overall costs to healthcare systems. Examples of devices include prefilled syringes, autoinjectors, on-body injectors, connected drug delivery devices, and more. Navigating and applying applicable FDA guidance documents in the development, commercialization, and lifecycle management for these devices can be challenging. Further, there is little FDA or ICH guidance on what delivery device information should be provided in IND/NDA/BLA applications that will undergo a CDRH consulting review. With many drug-device combination products under development, providing the right level detail on testing completed is essential for success. Examples of device content plans in the eCTD structure will be explored.

* One lucky attendee will win a copy of the book RAPS International Combination Products book.