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When do you approach the agency with a waiver request

Customer Question

when do you approach the agency with a waiver request for pediatric studies
Submitted: 8 months ago.
Category: Legal
Expert:  Briarcliff767 replied 8 months ago.

Hi, My name is ***** ***** I am happy to assist you.

A sponsor must submit the iPSP before the date on which the sponsor submits the required assessments and not later than 60 calendar days after the date of the end-of-phase 2 meeting.

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm360507.pdf The link I provided gives the complete rules and regulations. If you have further questions please feel free to respond.

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