It's unfathomable that the FDA can delay an approval for 6 months based on how an instruction leaflet is folded and what's written on an applicator or box. That could be fixed in a day. Another human study at $150K to do what? Open the leaflet longways instead of sideways?
Deliberate delaying tactics by the FDA for reasons probably never known. They need to introduce a short term review for anything green on a CRL.
Ann: FDA Letter Requires Patient Instruction Update, page-157
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