Kedrion BLA Email, October 20, 2010 - Kedbumin
From: Allard, Crystal
Sent: Wednesday, October 20, 2010 11:14 AM
Subject: Kedrion BLA 125384/0
We're making our way through the postmarketing SAS files and we have a few questions.
In the data_import dataset, there is a variable, medicinalproduct, which includes 'TALC' and other products in addition to albumin.
1) Is TALC a coded variable? If so, please provide a decode, including at least the proper and proprietary names of this drug.
2) There are other, possibly coded drugs (prednison, furosemide, etc.) listed under medicinalproduct. Please provide a decode, including at least the proper and proprietary names of these drugs.
2) Please explain the reason for inclusion of drugs other than albumin in this dataset.
Generally, for all data submitted, we ask that any coded variable have a decode provided either in the dataset or the define file. Also, the define file should include a column, comments, in which the source of each variable is generally listed. The comments column can also include a brief reason for inclusion. The study data specification guidance states "For derived variables, the method for calculating the variable should be included in the comments field. For raw variables, the location of the variable on the annotated CRF should be provided as well as the CRF field name if different from the variable name in the dataset. " I understand the variables in your datasets may not have come from CRFs, but the source information is very helpful to reviewers for all types of data.
For now, we don't need updated datasets or define files (just answers to the questions), but I thought this information might be helpful to you in the future. You can send your responses to me via email and I'll have then
Feel free to contact me with any questions or concerns.
Crystal Allard, RAC
Regulatory Project Manager
U.S. Food & Drug Administration
CBER/ OBRR/ DBA/RPMB
WOC1; RM480N; HFM-380
1401 Rockville Pike
Rockville, MD 20852
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