Posts Tagged ‘FDA rejections’
5 Green Flags the FDA Looks for in CGT CMC and How to Get Them
Roughly 50 to 75 percent of FDA rejections in cell and gene therapy are not about safety or efficacy. They are due to CMC and manufacturing deficiencies. In short, most programs do not fail because the science does not work. They fail because the manufacturing story is not strong enough. (Sources: Jefferies analysis of FDA…
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