


Information Request Email, February 8, 2012 - Hyqvia




  
From: Maruya, Aiko [Aiko_Maruya@baxter.com]
 Sent: Wednesday, February 08, 2012 1:05 PM
 To: Landow, Laurence
 Cc: Blackshere, Angela L; Shields, Mark
 Subject: RE: IGSC + rHuPH20: Study 161001

Attachments: Response to 02-06-2012 FDA Request for Information 2.pdf

Dear Dr. Landow,

Attached please find Baxter’s response to your questions regarding:
  a schematic for Disposition of Subjects for Study 160602
  the number of subjects 12-16 and 2-12 years of age enrolled in Study 160603.

Aiko

Aiko Maruya, M.S., RAC
 Sr. Manager / Regulatory Affairs
 BioScience
 Baxter Healthcare Corporation
 T (805) 372-3056 direct / Tie-line (b)(4)
 F (805) 372-3052
 aiko_maruya@baxter.com

From: Landow, Laurence [mailto:Laurence.Landow@fda.hhs.gov] 
 Sent: Monday, February 06, 2012 12:15 PM
 To: Maruya, Aiko
 Subject: RE: IGSC + rHuPH20: Study 161001

Ms. Maruya,

For Study 160603, please indicate the page numbers where the number of subjects 
12-16 and 2-12 years of age enrolled in the study is presented.

Thank you,

Laurence Landow


From: Maruya, Aiko [mailto:Aiko_Maruya@baxter.com] 
 Sent: Monday, February 06, 2012 1:35 PM
 To: Landow, Laurence
 Subject: RE: IGSC + rHuPH20: Study 161001

I confirm receipt of the attached message.  Aiko

From: Landow, Laurence [mailto:Laurence.Landow@fda.hhs.gov] 
 Sent: Monday, February 06, 2012 6:05 AM
 To: Maruya, Aiko
 Cc: Landow, Laurence
 Subject: RE: IGSC + rHuPH20: Study 161001

Good morning Ms. Maruya,

Kindly email a schematic for Disposition of Subjects for Study 160602.

Thank you,

Laurence Landow


From: Maruya, Aiko [mailto:Aiko_Maruya@baxter.com] 
 Sent: Wednesday, January 04, 2012 11:53 AM
 To: Landow, Laurence; 'aiko.maruya@baxter.com'
 Cc: Shields, Mark
 Subject: RE: IGSC + rHuPH20: Study 161001

I confirm receipt of the attached message. Aiko

Aiko Maruya, M.S., RAC
 Sr. Manager / Regulatory Affairs
 BioScience
 Baxter Healthcare Corporation
 T (805) 372-3056 direct / Tie-line (b)(4)
 F (805) 372-3052
 aiko_maruya@baxter.com


From: Landow, Laurence [mailto:Laurence.Landow@fda.hhs.gov] 
 Sent: Wednesday, January 04, 2012 6:31 AM
 To: 'aiko.maruya@baxter.com'
 Cc: Shields, Mark; Landow, Laurence
 Subject: IGSC + rHuPH20: Study 161001

Ms. Maruya,

I note that Figure 14.1.1-1 in Final Study Report 160601 and Figure 10.1-1 in 
Final Study Report 160603 present a schematic indicating Disposition of 
Subjects.

Please indicate the page number in Final Study Report 161001 where a similar 
schematic (Figure) can be found. If such a figure is not included in Final Study 
Report 161001, please submit it to the file as soon as possible.

Thank you

Laurence Landow MD, FRCPC
 301.827.6108
 laurence.landow@fda.hhs.gov
 Medical Officer, Clinical Review Branch
 Food and Drug Administration, CBER
 Office of Blood Research & Review
 Division of Hematology
 1401 Rockville Pike
 HFM-392
 Room 425N
 Rockville MD 20852


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