CBER Reorganization Aims To Fight Recruitment Challenges, Tackle Upcoming Gene Therapy Wave
A growing focus on real-world evidence and an expected infusion of user fee funding are among the reasons for the new office branches at US FDA’s biologics center.
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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 group will be called the Office of Therapeutic Products, but needs more people to handle its increasing workload.
A quickened shift toward gene therapies for small populations may be the result of the new Medicare drug pricing law given protections afforded to those types of products.