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Re: LaddyMan post# 19424

Wednesday, 10/28/2015 11:48:27 AM

Wednesday, October 28, 2015 11:48:27 AM

Post# of 118409
Laddyman, I'm not qualified to comment on 30 day approval if nothing said. I do recall reading that along the way when an IND is submitted, but not sure if it applies when IND is submitted, then FDA responds with questions and qualifications and further data needed.

Does 30 day no answer approval apply each time a company responds to FDA questions or new data requests? I don't know.