	  Fractionated Plasma Products > Filing Letter - January 16, 2009 - Gammaplex  
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Filing Letter - January 16, 2009 - Gammaplex




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Bio Product Laboratory

Attention:  Dr. Andrew West-Watson 
Daggar Lane
Elstree, Hertfordshire  WD6 3BX
United Kingdom
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:

Clinical
  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.

Epidemiology
        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.

Sincerely yours,

 

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
 

   
 


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