
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

 