form 1572 [Regulatives / Guidelines]

posted by Ohlbe – France, 2008-10-26 01:51 (6436 d 20:39 ago) – Posting: # 2582
Views: 2,124

Dear Krishnamurthy,

❝ for IND applications we know it should be

❝ submitted in advance before the start of the study


I am not so familiar with FDA requirements, but... isn't this the only situation where you officially need a 1572 ? I mean, to comply with regulatory requirements, not just to please the sponsor.

Regards
Ohlbe

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