Search SciPol

Brought to you by
November 17, 2017

FDA announces comprehensive regenerative medicine policy framework

  • Government
  • Agency
  • Genetics/Genomics

FDA News – Today the U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.

The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products. Further, two of the guidance documents propose an efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area.

Read more at FDA News.