https://www.biospace.com/asgct2024-fda-s-marks-on-accelerated-approval-gene-therapy-costs-and-more
The public utterances of the heads of regulatory agencies and their timing matter, be they in the pharma or other industries. These people are tasked to communicate the regulatory stance on various things and changes thereof to the public.
I view this as another indication that the FDA feels reasonably adequately resourced and led by the right people to start making real inroads into approving CGTs (Marks’ praise of Dr. Verdun was unreserved).
The focus is on the change in resourcing at the agency.
Cell Therapy News/Articles, page-18192
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