Combination products have the potential to offer novel alternatives for patient care through the unique combination of drugs, medical devices and/or biological products to produce therapeutic or diagnostic results not seen when independently utilized. However, usage of these products raises several challenges in defining specific regulatory requirements and policy because the constituent parts of the combination product are regulated using differing regulatory paradigms through different FDA Centers (CDER, CBER or CDRH).
This course provides a historical perspective on combination product regulation in the US and examines the current regulations and policies covering the identification, jurisdiction and review of combination products. It covers premarket activities, applicability of Good Manufacturing Practice (GMP) and postmarket requirements, such as adverse event reporting, inspection and enforcement.
Learning Objectives
Upon completion of this course, participants should be able to:
- Define key terminology, such as for a drug, device or biological product, and explain how those definitions help form the basis for the definition of a combination product
- Describe how a Primary Mode of Action (PMOA) is determined and its role in establishing product jurisdiction
- Cite the type(s) and number of investigational and marketing applications that may be filed for a combination product, and the associated user fees
- Explain the importance of, and prepare and implement a strategy for educating, communicating and interacting with FDA throughout the regulatory process
- Discuss some of the unique challenges of fulfilling premarket activities for combination products and identify existing guidance and regulation in this area
- Discuss the scope of GMP requirements for combination products
- Describe the requirements for postmarket safety reporting combination products
- Discuss the inspection and enforcement of combination product requirements
Target Audience
This course is designed for regulatory professionals and others in related departments interested in understanding the basics of combination product regulation in the US.