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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

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Published on: December 11, 2016

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.

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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.