US Food and Drug Administration international collaborations for cellular therapy product regulation

@inproceedings{Arcidiacono2012USFA,
  title={US Food and Drug Administration international collaborations for cellular therapy product regulation},
  author={Judith A Arcidiacono and Joan W Blair and Kimberly A. Benton},
  booktitle={Stem Cell Research & Therapy},
  year={2012}
}
Cellular therapy products are an emerging medical product class undergoing rapid scientific and clinical innovation worldwide. These products pose unique regulatory challenges both for countries with existing regulatory frameworks and for countries where regulatory frameworks for cellular therapy products are under development. The United States Food and Drug Administration (US FDA) has a history of productive working relationships with international regulatory authorities, and seeks to extend… CONTINUE READING