Key Takeaways
- The US regulator has less strict requirements than the EU for supporting cell and gene therapies through development and authorization, two experts say.
- The US Regenerative Medicine Advanced Therapy designation was also described as having less strict entry criteria than the EU PRIME scheme.
- Another expert praised the RMAT scheme and said it offered companies with easy access to senior figures at the Food and Drug Administration.
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...
Bartido’s comments were made as part of a panel discussion at the Advanced Therapies Congress held in London, UK on 19 March. Other panelists, including Medus AB’s head of regulatory...
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