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MedResCollab

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MedResCollab

Re: rafunrafun post# 198766

Thursday, 06/27/2019 3:20:52 PM

Thursday, June 27, 2019 3:20:52 PM

Post# of 425927

please show me any mention of 55 days from FDA's website / policy. -Rafun



See pg 17 here:

https://www.fda.gov/media/75436/download

However, it’s aged guidance, and not quite applicable to apps in PDUFA V and VI programs.

...

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