Lexology September 26, 2023
Morgan, Lewis & Bockius LLP

FDA’s Center for Biologics Evaluation and Research (CBER), the locus of regulating cell and gene therapies among other expanding areas of biotech, is poised for change on a number of important fronts—leadership, significant growth, and plans to address challenging scientific and regulatory issues. With a well-earned reputation of stability, and slow, plodding progress, moments with so many elements in flux at FDA don’t come around often, so it is worth keeping an eye on how these begin to unfold to have a sense of where CBER—central to many of the exciting developments in industry—is headed.

Reorganization

Earlier this year, CBER underwent a reorganization that, most notably, established the Office of Therapeutic Products (OTP) as a “Super-Office” within the center. With...

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