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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Draft Note Email, July 14, 2011 - Anascorp

 

From:                     Fisher, Robert
Sent:                      Thursday, July 14, 2011 5:08 PM
To:                         Cordaro, Debbie
Subject:                 RE: I have a draft note to Dov/Jay/Ginette see below
Yes!!!!
 
_____________________________________________
From:                     Cordaro, Debbie 
Sent:                      Thursday, July 14, 2011 17:04
To:                          Fisher, Robert
Subject:                RE: I have a draft note to Dov/Jay/Ginette see below
 
With the exception of ------(b)(4)-------, are you accepting their PMCs?

Debbie
 
Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR
Voice: 301-827-6157
debbie.cordaro@fda.hhs.gov
 
 
_____________________________________________
From:                     Fisher, Robert 
Sent:                      Thursday, July 14, 2011 3:16 PM
To:                          Scott, Dorothy
Cc:                          Cordaro, Debbie
Subject:                RE: I have a draft note to Dov/Jay/Ginette see below
 
They agreed to all of our PMCs, although for PMC #4 ----------------------------------------------------------------(b)(4)---------------------. 
 
_____________________________________________
From:                     Scott, Dorothy 
Sent:                      Thursday, July 14, 2011 13:18
To:                          Fisher, Robert
Subject:                RE: I have a draft note to Dov/Jay/Ginette see below
 
O.k. 
 
_____________________________________________
From:                     Fisher, Robert 
Sent:                      Thursday, July 14, 2011 1:16 PM
To:                          Scott, Dorothy
Subject:                RE: I have a draft note to Dov/Jay/Ginette see below
 
Give me a few minutes to look over the PMC responses (received today). If they have agreed to everything, then that's a big plus we can include in the note.
 
_____________________________________________
From:                     Scott, Dorothy 
Sent:                      Thursday, July 14, 2011 12:57
To:                          Cordaro, Debbie; Fisher, Robert
Subject:                I have a draft note to Dov/Jay/Ginette see below
 
 
I'd like to propose a timeline for Dov, then Jay/Ginette to review the PI. I will send a note Jay Eltermann's comments attached (but not ours). How is this?
 
Dear Jay, Ginette, and Dov,
As you can see from Jay's response, OCBQ is not going to be able to approve this submission on an accelerated timeline.
We (Robert and I) will be available for questions any time by blackberry or cell phone throughout this process. We will have our computers at work and at home, during on and "off" hours to be available. Can we do anything additional to assist?
Current status - awaiting final memoranda, due on the 20th. Package insert with revisions was sent to Bioclon, but there may be additional changes based on a final review. We will address any of those as soon as possible. PMC's so far are all CMC.
Dot