The US Food and Drug Administration takes a “more pragmatic” approach to cell and gene therapy development, which provides companies with a “less stringent pathway” to show that their product has potential, according to Shirley Bartido, Takeda’s director of global regulatory affairs, cell therapy oncology.
US Approach To Cell And Gene Therapy Regulations ‘Less Strict’ Than EU
Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
