Scientific Wave Pushes CBER Into Brighter Light
What are US regulators doing to prepare for adequate review of the upcoming wave of gene therapy applications, and what other actions could CBER take to ensure it is able to facilitate the expected onslaught of breakthroughs in this field? Consultant Nancy Bradish Myers weighs in.
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Final gene therapy IND CMC guidance clarifies expectations on process evolution, distinguishing drug substances from products, cGMP oversight and more.
US FDA CBER Chief Calls For Industry-Academia Collaboration In Developing Treatments For Ultra-Rare Diseases
The head of the US FDA’s Center for Biologics Evaluation and Research said that new approaches are needed to facilitate product development for ultra-rare diseases. The FDA also announces the creation of a new CBER Advanced Technologies Team to promote the adoption of innovative manufacturing technologies for cell and gene therapy products.
With approval of AbbVie Inc./Genentech Inc.'s Venclexta as seventh under RTOR pilot, a roughly two-month median review time under the program could be taking shape.