Framework for the regulation of regenerative medicine products

21 May 2019 - The U.S. FDA has published four final guidance documents that are part of a comprehensive policy framework ...

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Advanced therapy medicinal products and health technology assessment principles and practices for value-based and sustainable healthcarehe

1 April 2019 - Advanced therapy medicinal products are beginning to reach European markets, and questions are being asked about their ...

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FDA advances new efforts to promote development of safe and effective regenerative medicine products

15 February 2019 - Today, the FDA finalised two guidance documents regarding regenerative medicine therapies.  ...

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Hope for regenerative medicine bonanza

30 October 2018 - Regenerative medicine could be worth $6 billion in annual revenue and 6,000 new jobs for Australia ...

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Rejuvenating regenerative medicine regulation

7 February 2018 - The FDA recently made long-awaited progress toward protecting patients from interventions involving human cell- and tissue-based products ...

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Mesoblast receives FDA regenerative medicine advanced therapy designation for its cell therapy in heart failure patients with left ventricular assist devices

21 December 2017 - Mesoblast today announced that the United States FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for ...

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Statement from FDA Commissioner on FDA’s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health

16 November 2017 - One of the most promising fields of science is the area of cell-based therapies and their ...

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FDA announces comprehensive regenerative medicine policy framework

16 November 2017 - Framework aims to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy. ...

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