Documents

FDA proposes framework for individualized gene therapies as CMS expands access

Biotech top-pharma -
The US Food and Drug Administration (FDA) has proposed a regulatory framework for individualized human genome editing therapies, while the Centers for Medicare &...

Council of Europe proposes regulatory framework for human organs manipulated ex situ

Advanced Therapies top-pharma -
The European Committee on Organs, Tissues and Cells (CD-P-TO) of the Council of Europe, with Secretariat support from the European Directorate for the Quality...
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