TORONTO, ON--(Marketwired - March 20, 2017) - In a special presentation, Diane Beatty, PhD, Managing Director of Regulatory Affairs and Product Development and Jean Dehdashti, MSc, RAC, Scientist III Regulatory Affairs & Product Development both from Cardinal Health Regulatory Sciences will discuss their experience with the regulatory and product development processes for combination products to show you how to navigate regulatory complexities. The live broadcast takes place on Wednesday, April 5, 2017 at 2pm EDT.
Understanding Combination Product regulatory requirements as determined by the FDA is critical in establishing a successful development path for the ultimate approval and/or clearance of a combination product. In addition, for novel combination products or novel indications of historically approved combination products, it can become daunting to formulate the argument for the primary mode of action (PMOA) and to navigate the Office of Combination Products' jurisdictional process of Request for Designation (RFD).
Topics will include:
- FDA's classification of combination products and regulatory requirements for corresponding drug and device constituents
- Role of Office of Combination Products (OCP), understanding the process for Request for Designation (RFD), and the significance of the Primary Mode of Action (PMOA)
- The impact of the 21st Century Cures Act on FDA jurisdiction decisions for combination products
- The importance of ensuring your development program adequately supports FDA marketing approval and post-market requirements
- Critical attributes to consider in designing an effective combination product development program
To learn more about this event visit: Combination Product Regulatory Requirement Complexities and the Impact of the 21st Century Cures Act
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