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Combination products: modernizing the regulatory paradigm
Nina L Hunter1, Rachel E Sherman1
1Office of Medical Products and Tobacco, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
Nature Reviews. Drug Discovery
|May 13, 2017
Summary
The U.S. Food and Drug Administration (FDA) is developing a science-based regulatory framework for innovative combination products. This approach aims to be modern, transparent, and flexible for complex drug-device products.
Area of Science:
- Regulatory Science
- Biopharmaceutical Product Development
- Medical Device Regulation
Background:
- Increasing development of complex products combining drugs, devices, and biologicals.
- Emerging regulatory challenges for these innovative combination products.
- Need for a modernized regulatory framework.
Purpose of the Study:
- To discuss the U.S. Food and Drug Administration's (FDA) ongoing efforts.
- To outline the development of a new regulatory approach for combination products.
- To highlight the characteristics of the intended regulatory framework: modern, transparent, flexible, and consistent.
Main Methods:
- Review of current FDA initiatives and strategic planning for combination products.
- Analysis of the principles guiding the development of the new regulatory framework.
- Discussion of the science-based foundation for regulatory decision-making.
Main Results:
- The FDA is actively working on establishing a comprehensive regulatory strategy.
- The new approach emphasizes flexibility, transparency, and scientific rigor.
- Efforts are focused on ensuring a consistent regulatory pathway for diverse combination products.
Conclusions:
- The FDA's evolving regulatory approach aims to facilitate innovation in combination products.
- A science-based, adaptable framework is crucial for addressing complex product development.
- The initiative seeks to provide clarity and consistency for manufacturers.
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