
Record of Telephone Conversation, October 6, 2009 - Flublok

 
 

Submission Type: Original Application   Submission ID:  125285/0   Office: OVRR  

 

Product:

Influenza Vaccine

 

Applicant:                                                                        

Protein Sciences Corporation          

 

Telecon Date/Time:  06-OCT-2009 02:15 PM              Initiated by FDA?  Yes

Telephone Number:  203-599-6064

 

Communication Categorie(s):

Information Request

 

Author:  TIMOTHY FRITZ

 

Telecon Summary:

Dr. Penny Post was called to clarify some details of the September 24, 2009 face-to-face meeting with CBER.

 

FDA Participants:  

Timothy Fritz

 

Non-FDA Participants:   

Penny Post

 

Trans-BLA Group: No

    

Related STNs:  None

 

Related PMCs:  None

 

Telecon Body:

Dr. Post was phoned to ask for clarification regarding details of the September 24, 2009 face-to-face meeting between Protein Science Corporation (PSC) and FDA.

 

Dr. Post was asked if she cold provide:

1.         The names of the BARDA attendees at the meeting

2.         The title of Dr. Peter Cardinal

3.         Clarification on item 1t that –b(4)----------------------- would be addressed on a strain-specific basis, and

4.         Clarification on item 1w regarding whether PSC indicated that it would repeat the container closure integrity validation using 3 lots.

 

Dr. Post indicated that she would email a response as soon as possible.

 