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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2/16/2007 Telecon Information Request - RECOTHROM

TO: ZymoGenetics, Inc.
RE: STN 125248.0 Original Application Thrombin (Recombinant)

Request for additional information:

  • Please provide a justification for the --------------------------------------------- drug substance.
  • Please explain if integrity testing of the final bulk container/closure was performed. If so, please provide a summary of the results. Please provide a justification if testing is not performed.
  • Please explain why the ------------------------------------------------------------------------------------------------------------
    -------------------------------------------------------------.
  • Please provide translated summary reports for the following studies:
    • Sterilization of equipment, materials, and closures
    • Depyrogenation of final containers
    • Lyophilization of drug product
    • Media fills
  • Environmental Assessment
    • 21 CFR 25.31(e) is quoted as the reason for categorical exclusion. This is only relevant for an IND. Please consider using a different categorical exclusion justification such as 21 CFR 25.31(c) ,naturally occurring substance.
  • Please provide a translation of the investigation report for the deviation regarding "popped-up stoppers" identified after lyophilization of final product.

END

 

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