
Information Request Email, March 4, 2011 - Anascorp

 

 
From:                     Cordaro, Debbie

Sent:                      Friday, March 04, 2011 11:38 AM

To:                         'Jennifer Spinella'

Subject:                 Information Request for STN 125335/0

Our Reference: BL 125335/0

 

Rare Disease Therapeutics, Inc

Attention: Ms. Jennifer Spinella

Sent by email

 

Dear Ms. Spinella:

 

We are reviewing your biologics license application for Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine). We determined that the following information is necessary to continue our review:

 

1. In response to our information request of February 9, 2011 you provided pdf files of data summary tables. The ISS results are based on patient level data/raw data and need to be verified. Please submit patient data listings in the form of SAS transport files for the ISS.

 

2. Additional patient data has been provided to this file which was not reflected in the original package insert submitted. Please include both a red-line strike out and clean copy of the revised package insert in WORD format.

 

The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission. 

 

If we determine that your response to this information request constitutes a major amendment, we will notify you in writing. Please submit your response to this information request as an amendment to this file by March 18, 2011 referencing the date of this request.

 

The action due date for this file is August 3, 2011.

 

If you have any questions, please contact me at (301) 827-6157.

 

Sincerely,

 

 

 

[RPM]

Regulatory Project Manager

FDA/CBER/OBRR/DBA/RPMB

 

 

Debbie Cordaro

 

Debbie Cordaro

Regulatory Project Manager

FDA/CBER/OBRR/DBA/RPMB

1401 Rockville Pike

Rockville, MD 20852

debbie.cordaro@fda.hhs.gov

Voice: 301-827-6157 Fax 301-827-2857

debbie.cordaro@fda.hhs.gov