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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Bristol Myers Squibb’s use of real-world evidence in US and EU marketing applications for three of its products shows how population bridging, external controls and comparative effectiveness might be employed.
Office of Tissues and Advanced Therapies seeks to optimize its organizational structure and adopt more group-level communications, instead of one-on-one interactions with sponsors, to keep up with the massive growth in cell and gene therapies, director Wilson Bryan says.