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  231   Postapproval Changes  

For post-approval site change of biologics, how to determine the shelf life for drug product manufactured at the new site?

  
  232   Postapproval Changes  

For biologics, what information should be provided for the change involving a drug product manufacturer/manufacturing facility?

  
  233   Postapproval Changes  

What is the consideration to use side-by-side comparison or historical data comparison for comparability studies of biologics?

  
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