Guess I’m childish to think out of nowhere after all these years, the FDA come out with a concern about “Citizens Petitions”. They can not judge the integrity of the source of the petition or that opens another can of worms!
Raf, they might have been forced to due to mandate.
“the FDA could not delay approving an ANDA due to concerns raised in a citizen petition unless the delay was "necessary to protect public health"; it also mandated that the FDA needed to respond to a petition within 180 days - this was shorted to 150 days in a 2011 amendment”
If the FDA felt the CP provided enough of an argument then by mandate they would have to take action on it. I am not sure if they treat sNDA’s and ANDA’s the same way, as even the new guidance everyone is talking about has to do with ANDA’s.
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