Advancing an agile regulatory ecosystem to respond to the rapid development of innovative technologies |
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| Authors: | M. Khair ElZarrad Aaron Y. Lee Rose Purcell Scott J. Steele |
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| Affiliation: | 1. Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring Maryland, USA ; 2. Department of Ophthalmology, School of Medicine, University of Washington, Seattle Washington, USA ; 3. Clinical and Translational Science Institute and Department of Public Health Sciences, University of Rochester Medical Center, Rochester New York, USA ;4.Present address: Takeda Pharmaceutical Company, Washington DC, USA |
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| Abstract: | ![]()
Technological advancements are dramatically changing the landscape of therapeutic development. The convergence of advances in computing power, analytical methods, artificial intelligence, novel digital health tools, and cloud‐based platforms has the potential to power an exponential acceleration of evidence generation. For regulatory agencies responsible for evidence evaluation and oversight of medical products, these advances present both promises and challenges. Ultimately, realizing the translation and impact of these innovations that could potentially enhance therapeutic development and improve the health of individuals and the public will require a nimble and responsive regulatory approach. Supporting an adaptive policy‐making infrastructure that is poised to address novel regulatory considerations, creating a workforce to ensure relevant expertise, and fostering more diverse collaborations with a broader group of stakeholders are steps toward the goal of modernizing the regulatory ecosystem. This article outlines approaches that can help provide the flexibility and tools needed to foster innovation, while ensuring the safety and effectiveness of medical products. |
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