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krishnamurthy ca ☆ 2008-10-22 07:21 (6440 d 19:46 ago) Posting: # 2576 Views: 2,634 |
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Dear all I would like to know when the form 1572 for USFDA should be submitted to sponsor for BA/BE studies. for IND applications we know it should be submitted in advance before the start of the study. (pl note: we ensure that the form is signed by the investigator before the study starts) tnks Krishnamurthy |
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Ohlbe ★★★ France, 2008-10-26 01:51 (6437 d 01:16 ago) @ krishnamurthy ca Posting: # 2582 Views: 2,126 |
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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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Ohlbe ★★★ France, 2008-10-28 17:39 (6434 d 08:28 ago) @ krishnamurthy ca Posting: # 2590 Views: 2,223 |
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Dear Krishnamurthy, Maybe you will find some answers to your questions in the draft Q&A published by the FDA last July. Regards Ohlbe |
Ing. Helmut Schütz