Bioequivalence and Bioavailability Forum • BE using non RLD

BE using non RLD [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-08-04 00:51 (4713 d 17:48 ago) – Posting: # 11189
Views: 6,362

Hi,

❝ Options: Submit and hope for the best, or petition FDA to make them designate RLD status to your comparator strength.

(FDA) Correct and they will not accept it unless you petition for approving the lower strength as a RLD.

John

Complete thread:

BE using non RLD zheng791 2013-08-03 21:45
- BE using non RLD ElMaestro 2013-08-03 22:17
  - BE using non RLDjag009 2013-08-03 22:51
    - BE using non RLD zheng791 2013-08-03 23:55
      - BE using non RLD jag009 2013-08-04 20:20
        
        BE using non RLD luvblooms 2013-08-05 05:57
        
        BE using non RLD ElMaestro 2013-08-05 10:44
        
        BE using non RLD luvblooms 2013-08-05 13:46
        
        BE using non RLD ElMaestro 2013-08-05 13:59
        
        BE using non RLD luvblooms 2013-08-05 14:31
        
        BE using non RLD ElMaestro 2013-08-05 15:04
        Very strange! jag009 2013-08-05 16:02
        
        Very strange! Helmut 2013-08-05 16:37
        
        Very strange! jag009 2013-08-05 16:45
        
        Very strange! luvblooms 2013-08-05 17:30
        
        Very strange! jag009 2013-08-05 17:52

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