Honestly when Bot said they were entering into labeling discussions I thought they would be signed off on approved and the name etc…. Would be ok ready for approval if granted. I struggle to see how an organization that is providing review and oversight can’t get their end right. They should provide feedback until everyone is happy. FDA should not have held up approval and provided clearer instructions and labeling should have been finalized.
Ann: Presentation- FDA Letter Requires Patient Instruction Update, page-58
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