New Name, Old Problems: US FDA’s Cell And Gene Therapy Office Still Facing Growth Challenges
The group will be called the Office of Therapeutic Products, but needs more people to handle its increasing workload.
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CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.
The COVID-19 pandemic is definitely not over when it comes to the workload facing the US FDA’s vaccine review team, even as the other biologics review operations get back ‘toward normal.’
OTAT Director Wilson Bryan says important cell and gene therapy guidances came from clear community needs, not user fee program requirements.