The FDA's new regenerative medicine framework: What does it mean for product development?

15 December 2017

Dr Nicola Davies discusses the US Food and Drug Administration’s (FDA) new framework on regenerative medicine that is aimed at spurring innovation in transformative products while ensuring safety and efficacy.

The field of regenerative medicine is broad and spans disciplines including tissue engineering, stem cell research, gene therapy and nanotechnology.1 This area of medicine is constantly evolving, and as new discoveries are made, and new technologies developed, there is a need for regulatory frameworks to guide companies through the research and development process.

The issue of encouraging innovation is an area that must also be addressed. Conducting research into new, and uncharted, territory can be a lengthy process. However, because these products will be aimed at treating unmet medical needs in patients, there is a clear motivation to bring these ground-breaking products to market as quickly as possible. So, what are authorities doing to encourage development and help make these products a reality?

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