It’s a pretty poor system if you spend a year and a half...

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    It’s a pretty poor system if you spend a year and a half preparing a resubmission, just for the FDA to set you back another 12 months. Why is it like an exam you study for where you need to get 100% and not a feedback process? If your product meets the safety data end point, it should not be judged by a 100% test result.



 
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