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Vaccines, Blood & Biologics

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.


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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