• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

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

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448