
Record of Telephone Conversation, October 1, 2009 - Flublok

 
Product:

Influenza Vaccine

 

Applicant:                                                                       

Protein Sciences Corporation          

 

Telecon Date/Time:  01-OCT-2009 01:44 PM              Initiated by FDA?  Yes

Telephone Number:    

 

Communication Categorie(s):

1. Advice

2. Information Request

 

Author:  TIMOTHY FRITZ

 

Telecon Summary:

Information Request regarding process validation of Flublok. In response to OS review and review of Aug 25, 2009 response to July 30, 2009 CBER IR.

 

FDA Participants:  

Timothy Fritz

 

Non-FDA Participants:   

Penny Post

 

Trans-BLA Group: No

    

Related STNs:  None

 

Related PMCs:  None

 

Telecon Body:

Hi Penny-

 

Attached is CBER's information request.

 

Thanks,

Tim

 

Timothy A. Fritz, Ph.D.

Microbiologist

FDA/CBER/OVRR/DVRPA/RRB2

WOC1 HFM-478 Suite 371N

1401 Rockville Pike

Rockville, MD 20852

Phone: 301-827-3070

Fax: 301-827-1597

 

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