
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
