
Meeting Cover Letter - Bivigam

 
 

Our Reference: CRMTS #8670                                              Division of Blood Applications

                         STN 125389/0                                               Telephone: (301) 827-3524

 

 

Biotest Pharmaceuticals Corporation

Attention: Gary Ingenito, M.D., Ph.D.

5800 Park of Commerce Boulevard., N.W.

Boca Raton, FL  33487

 

Dear Dr. Ingenito:

 

Attached is a copy of the memorandum summarizing your September 10, 2012 Type A meeting with CBER. Please note that although cited in the summary, we have not attached copies of materials you supplied. This memorandum constitutes the official record of the meeting. If your understanding of the outcomes differs from those expressed in this meeting summary, it is your responsibility to bring these discrepancies to CBERs attention for resolution. 

 

If you have any questions, please contact Pratibha Rana at (301) 827-6124.

 

Sincerely yours, 

 

 /s/

 

Iliana Valencia, M.S.

Chief, Regulatory Project

 Management Branch

Office of Blood Research and Review

Center for Biologics

 Evaluation and Research