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Wednesday, October 14, 2020 6:47:00 AM
Prior to covid, the fda had 21 days to respond to a pre-ind/type b meeting request and then schedule the meeting within 60 days. the pre ind package is due 30 days prior to the date of the meeting or wro. minutes of the meeting are provided 30 days after the meeting happens.
Post covid, what's the timeframe? Other than the completeness of the pre ind package, there is no timeframe like mentioned above. Seeing how we heard back in less then 1 week compared to 3 weeks pre-covid, then i assume things take 1/3 the amount of time... that being said, instead of 60 days to schedule the meeting, it would be 20 days. We are inching up real fast on day 20.
the above is all IMHO (consider this my safe harbor statement)
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