A study that is undertaken with a bunch of people to show that the instructions are understood and the product is applied properly. It is not a clinical study - but simply a study to see that all is understood and product applied - turnaround about 2 months.
Should be completed Jan 24
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- Ann: FDA Confirms Approach to Sofdra NDA Resubmission
Ann: FDA Confirms Approach to Sofdra NDA Resubmission, page-12
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