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

posted by Ohlbe – France, 2013-10-01 17:41 (4654 d 04:58 ago) – Posting: # 11584
Views: 3,087

Hi John,

The Guidance on submission of summary BE data for ANDAs refers in lines 90-96 to the summary tables which can be found on FDA's web site.

—
Regards
Ohlbe

Complete thread:

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

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