To get there, Marks and CBER have a four-poin plant: improve manufacturing through new research, clarify the use of the accelerated approval pathway for gene therapies, coordinate regulatory decisions with other regulators and launch an Operation Warp Speed for rare diseases.
With an entire new department for cell and gene therapy now in place the FDA is poised to unleash multiple approvals in our space.
LVAD accelerated approval THIS YEAR , is very realistic.
Try before you die - it's my new slogan
Reg
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