Bioequivalence and Bioavailability Forum

FDA: antique of ’93 [Regulatives / Guidelines]

posted by jag009  – NJ, 2013-12-12 00:16 (4574 d 18:25 ago) – Posting: # 12041
Views: 14,902

Hi Helmut!

❝ So far? Unbelievable. Ask your legal department to get refund from the FDA for the study you performed exactly following the guidance only to get from SAS: WARNING: Did not converge...

They don't give refund... The govt just went through "sequester" this year...

Also it was a pilot study.

Strangely, I emailed FDA about stability and they replied back the next day!
Very responsive from that group!

John

Complete thread:

• FDA: Size of bio-batch Helmut 2013-12-10 14:05 
  • FDA: Size of bio-batch jag009 2013-12-10 20:03
    • FDA: antique of ’93 Helmut 2013-12-10 23:32
      • FDA: antique of ’93 jag009 2013-12-11 15:23
        • FDA: antique of ’93 Helmut 2013-12-11 15:26
          • FDA: antique of ’93 jag009 2013-12-11 16:21
            • FDA: antique of ’93 Helmut 2013-12-11 16:29
              • FDA: antique of ’93jag009 2013-12-11 23:16
                • Patience Helmut 2013-12-12 14:34
      • FDA: antique of ’93 Beholder 2018-06-21 09:21
        • Nice numbers Helmut 2018-06-21 15:05
          • Nice numbers Beholder 2018-06-22 10:33
            • Type II variation Helmut 2018-06-22 15:12
        • Birdsong's third law of BE ElMaestro 2018-06-22 10:10
          • Experience Beholder 2018-06-22 11:04
            • Why, oh why? Helmut 2018-06-22 15:17
              • Sorry for the delay Beholder 2018-10-18 09:40