Could US FDA Move Gene Therapy Regulation To Device Center In Years To Come?
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.
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Pilot program would get around the ‘one drug, one test’ policy, which has created intellectual property issues.
OTAT Director Wilson Bryan says important cell and gene therapy guidances came from clear community needs, not user fee program requirements.
The group will be called the Office of Therapeutic Products, but needs more people to handle its increasing workload.