
Request for Teleconference Email, September 20, 2013 - Hyqvia




  

 
From: Blackshere, Angela L [Angela_Blackshere@baxter.com]
Sent: Friday, September 20, 2013 7:06 PM
To: Shields, Mark
Cc: Shah, Alpa
Subject: RE: Request Re: STN BL 125402

Thanks, Mark. Baxter will send an email shortly.

Regards,

Angela

*************************************

Angela Blackshere
Sr. Director, Global Regulatory Affairs
Baxter Healthcare Corporation, Baxter BioScience
One Baxter Way
Westlake Village, CA 91362
(805) 372-3050/Phone
(805) 372-3052/Fax

From: Shields, Mark [mailto:Mark.Shields@fda.hhs.gov] 
Sent: Thursday, September 19, 2013 11:04 AM
To: Blackshere, Angela L
Cc: Shah, Alpa
Subject: RE: Request Re: STN BL 125105

Hi Angela,

We suggest you place your ideas into an email for discussion.

Thanks! 
Mark


From: Blackshere, Angela L [mailto:Angela_Blackshere@baxter.com] 
Sent: Friday, September 13, 2013 6:19 PM
To: Shields, Mark
Cc: Shah, Alpa
Subject: Request Re: STN BL 125105

Dear Mark:

Baxter would like to schedule an informal teleconference with FDA’s Nonclinical 
Pharm/Tox review team to discuss technical details associated with a preclinical 
study to address FDA’s concern related to lifetime exposure to anti-PH20 
antibodies. We have a few ideas and want to ensure the experiment design will 
adequately address FDA’s concern before we formally make our proposal in the 
submission to the Complete Response letter in November. Please check the review 
team’s availability for a 30 minute teleconference for September 24-27, 2013.

Thanks and best regards,

Angela

*************************************

Angela Blackshere

Sr. Director, Global Regulatory Affairs
Baxter Healthcare Corporation, Baxter BioScienceOne Baxter Way
Westlake Village, CA 91362
(805) 372-3050/Phone
(805) 372-3052/Fax

The information transmitted is intended only for the person(s) or entity to 
which it is addressed and may contain confidential and/or legally privileged 
material. Delivery of this message to any person other than the intended 
recipient(s) is not intended in any way to waive privilege or confidentiality. 
Any review, retransmission, dissemination or other use of, or taking of any 
action in reliance upon, this information by entities other than the intended 
recipient is prohibited. If you receive this in error, please contact the sender 
and delete the material from any computer.

For Translation:

http://www.baxter.com/email_disclaimer

The information transmitted is intended only for the person(s) or entity to 
which it is addressed and may contain confidential and/or legally privileged 
material. Delivery of this message to any person other than the intended 
recipient(s) is not intended in any way to waive privilege or confidentiality. 
Any review, retransmission, dissemination or other use of, or taking of any 
action in reliance upon, this information by entities other than the intended 
recipient is prohibited. If you receive this in error, please contact the sender 
and delete the material from any computer.

For Translation:

http://www.baxter.com/email_disclaimer
 
 

  