Regenerative and stem cell therapy practices part 20

Stem cell 2

 

The 21st Century Cures Act, signed into law in December of 2016, represents legislative efforts at the federal level to expand and accelerate patient access to treatment, in addition to promoting innovation in medical products and treatments. With respect to regenerative medicine, the Act amend Section 506 of the Federal Food, Drug and Cosmetic Act by requiring expedited review for regenerative medicine therapies, including human cells and tissues, intended to treat, modify, reverse, or cure a serious or life-threatening disease or conditions, where there is preliminary clinical evidence indicating that the drugs has the potential to address unmet medical needs. There is also ongoing efforts at the federal level to ensure even greater access to treatments that are not subject to FDA approval prior to administration to patients.

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