This paragraph from the article jumped out at me. Have a great weekend y'all.
"Expediting the development of these novel and transformative technologies like gene- and cell-based therapies doesn’t necessarily mean lowering the standard for approval, as I believe other countries have done. But it does mean having a framework that’s crafted to deal with the unique hypothetical risks that these products pose. It means shifting much more of the emphasis on active surveillance as opposed to FDA’s historically more binary approach to regulation, that transfers most of the responsibility to the pre-market review process."
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