Challenges of Drug/Devices Pharmaceutical Products
Due to significant differences in regulatory approaches and requirements by different review centers within FDA, design of a stability program to support the development and approval of a drug/device combination product can present significant challenges. Having an in-depth understanding of the stability issues and regulatory requirements associated with this type of drug/device combination products is critical to avoid the costly delay of the product development and marketing approval.
KeywordsCombination Product Marketing Approval Stability Program Drug Component Device Component
•Steve Koepke, Ph.D. SRK Consulting
•Stuart Portnoy, M.D. PharmaNet Inc.