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FDA Submission: Failed and pilot studies [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-10-01 17:14 (4648 d 14:41 ago) – Posting: # 11582
Views: 3,647

Hi guys,

Does anyone know what FDA requires to submit for failed and/or pilot study(s)? Would a study synopsis (with results) and DBE table be sufficient?

Thanks

John

Complete thread:

FDA Submission: Failed and pilot studiesjag009 2013-10-01 15:14
- FDA Submission: Failed and pilot studies Ohlbe 2013-10-01 15:41
  - FDA Submission: Failed and pilot studies jag009 2013-10-01 16:33

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