
2/2/2007 Filing Meeting Email - RECOTHROM

 
 
From: Gallagher, Maryann 

Sent: Friday, February 02, 2007 11:25 AM 

To: Shields, Mark 

Cc: Lee, Timothy; Drews, Roman T 

Subject: RE: 125248.0 Filing Meeting 

Please file this email regarding the time frame for the submission of the proposed proprietary name.

Thanks,
 Maryann

Maryann Gallagher
 Consumer Safety Officer
 Advertising and Promotional Labeling Branch
 CBER/OCBQ/DCM
 1401 Rockville Pike
 Rockville, Md. 20852-1428
 301-827-3028
 fax 301-827-3528
 maryann.gallagher@fda.hhs.gov


From: Shields, Mark 

Sent: Friday, February 02, 2007 11:23 AM 

To: Gallagher, Maryann 

Cc: Lee, Timothy; Drews, Roman T 

Subject: RE: 125248.0 Filing Meeting 

Hello Maryann and Tim,

They plan to submit proprietary names in April. Final Action due date is 18-Oct-2007.

Please provide an email that states that this can be filed.

Thanks!

Mark A. Shields
 Regulatory Project Manager
 HFM-380 FDA/CBER
 Office of Blood Research and Review
 Division of Blood Applications
 email: mark.shields@fda.hhs.gov


From: Gallagher, Maryann 

Sent: Friday, February 02, 2007 11:19 AM 

To: Shields, Mark 

Cc: Lee, Timothy 

Subject: RE: 125248.0 Filing Meeting 

When's the approval date? Since their other 2 names were unacceptable, they should submit something soon for our review.

Thanks,
 Maryann


From: Shields, Mark 

Sent: Friday, February 02, 2007 10:46 AM 

To: Gallagher, Maryann 

Cc: Lee, Timothy 

Subject: RE: 125248.0 Filing Meeting 

Not yet.

Mark A. Shields
 Regulatory Project Manager
 HFM-380 FDA/CBER
 Office of Blood Research and Review
 Division of Blood Applications
 email: mark.shields@fda.hhs.gov


From: Gallagher, Maryann 

Sent: Friday, February 02, 2007 7:31 AM 

To: Shields, Mark 

Cc: Lee, Timothy 

Subject: RE: 125248.0 Filing Meeting 

Has Zymogenetics submitted a request for review of a proposed proprietary name ? The 2 previous names -------------- and -------------- were unacceptable.

Thanks,
 Maryann

Maryann Gallagher
 Consumer Safety Officer
 Advertising and Promotional Labeling Branch
 CBER/OCBQ/DCM
 1401 Rockville Pike
 Rockville, Md. 20852-1428
 301-827-3028
 fax 301-827-3528
 maryann.gallagher@fda.hhs.gov


From: Shields, Mark 

Sent: Thursday, February 01, 2007 1:01 PM 

To: Aebersold, Paul; Drews, Roman T; Gallagher, Maryann; Hshieh, Paul; Buehler, Paul (CBER); Kirschbaum, Nancy; Lee, Timothy; Lindsey, Kimberly; Renshaw, Carolyn; White, Janet; Buehler, Paul (CBER) 

Subject: 125248.0 Filing Meeting 

Hi Roman,

I have had no response for the Filing Meeting from K. Lindsey, M. Gallagher, or T. Lee.

I have these (attached) comments from P. Aebersold that I will fax to ZymoGenetics, Inc. << File: 125248.0 Information Request to be faxed 01-Feb-07.doc >>

Are there any additional issues we want to address with Zymo?

Thanks!

Mark A. Shields
 Regulatory Project Manager
 HFM-380 FDA/CBER
 Office of Blood Research and Review
 Division of Blood Applications
 email: mark.shields@fda.hhs.gov
