which is why surely subjective / personal opinion by FDA as opposed to feedbcak based on written guidelines and framework around labelling and insx is worthy of appeal at least...
esp since patient studies had passed the test and shown no issues based on existing, mind you, 6th version , insx.
smells of corruption to me, typical FDA
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- Ann: Presentation- FDA Letter Requires Patient Instruction Update
Ann: Presentation- FDA Letter Requires Patient Instruction Update, page-54
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