remember that the wording was already there on the bottle and on the carton.
the NEW request from the fda was to "make it more prominent'.
"prominent" is not something that is defined it is subjective.
it is not in any information that can be looked up as it is the fda that stipulate based on its review of each product.
this is in same regards to the decision around changing the formatting of the instructions again not something that was specified as a requirement before hand.
remember the disappointment from management about it not being raised by the fda at prior feedback points.
Ann: Presentation- FDA Letter Requires Patient Instruction Update, page-52
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