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Re: Basin Street Blues post# 472536

Friday, 05/13/2022 11:26:01 AM

Friday, May 13, 2022 11:26:01 AM

Post# of 705516
BSB -

...however we seem to collectively accept that if they did not accept the changes they notify the company within 90 days .



FYI - That is exactly how the FDA works. I have had to do IND submissions to the FDA in the past and that is exactly what I was told about the process. If you notify the FDA of a proposed change and they do not respond or object in writing within 90 days, then that change is accepted as ok. There is no uncertainty in this interpretation.
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