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Hello,
The PSP guidance stats that once we submit the Agreed PSP FDA will take 30 day to review however I do not see any information on review timeline for any concerns/negotiation within 90 days of sponsor review of the agency feedback ?
what's a timeline for FDA to provide feedback once the sponsor submits the justification for non-agreement with the agency on some parts of the iPSP feedback. will that be 30 days.?
Thank You,