Bio Product Laboratory
Attention: Dr. Andrew West-Watson
Elstree, Hertfordshire WD6 3BX
Dear Dr. West-Watson:
This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.
We have completed an initial review of your application dated November 14, 2008 for Immune Globulin Intravenous (Human), 5% Liquid to determine its acceptability for filing. Under 21 CFR 601.2(a) we have filed your application today. The review goal date is September 17, 2009. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.
We will contact you regarding your proposed labeling no later than August 20, 2009. If post marketing study commitments (506B) are required, we will contact you no later than August 20, 2009.
While conducting our filing review, we identified the following potential review issues:
- The definitions in the datafiles have not been provided. Please submit explanations for the fields in each of the xpt files of the dataset.
- To facilitate reviewing the submission, please submit electronic files in Microsoft Word for Sections 1 to 13 of each clinical study report (GMX01 and GMX03).
- For AE datafiles, please provide additional columns relating to (a) infusion start time, (b) infusion end time, (c) whether event is between start time and within 48 hours of end of the infusion, and (d) whether event is between start time and within 72 hours of end of the infusion.
Please submit this information within two weeks of receipt of this letter.
- Please submit a pharmacovigilance plan.
Please contact the FDA to inform them as to when this information will be available.
We are providing the above comments to give you preliminary notice of potential review issues. Our filing review is only a preliminary evaluation of the application and is not indicative of deficiencies that may be identified during our complete review. Issues may be added, deleted, expanded upon, or modified as we review the application. If you respond to these issues during this review cycle, we may not consider your response before we take an action on your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.
If you have any questions, please contact the Regulatory Project Manager, Debbie Cordaro, at (301) 827-6157.
Jeffrey Anderson, MS, RAC
Chief, Regulatory Project Management Branch
Division of Blood Applications
Office of Blood Research and Review
Center for Biologic Evaluation and Research