
Record of Telephone Conversation, October 8, 2009 - Flublok

 

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

 

Product:

Influenza Vaccine

 

Applicant:                                                                        

Protein Sciences Corporation          

 

Telecon Date/Time:  08-OCT-2009 10:11 AM             Initiated by FDA?  No

Telephone Number:    

 

Communication Categorie(s):

Other

 

Author:  TIMOTHY FRITZ

 

Telecon Summary:

Response to CBER's October 6, 2009 Information Request for clarification of details of September 24, 2009 face-to-face meeting.

 

FDA Participants:  

Timothy Fritz

 

Non-FDA Participants:   

Penny Post

 

Trans-BLA Group: No

    

Related STNs:  None

 

Related PMCs:  None

 

Telecon Body:

 

Hi Tim,

 

Below are the answers to your questions regarding the September 24 BLA meeting:

 

1)  The attendees from BARDA were:  Dr. Maurice Harmon and Dr. Frank Arnold

2)  Comment 1t:  We indicated that we would set an upper specification on –b(4)--------------------- taking into account assay variability and strain specific trends . –b(4)------------------- over the specification would be investigated.

3)  Comment 1w:   We do not recall stating that 3 lots would be used to complete container closure integrity testing for shipping.  We feel that one lot with 3 shippers tested would be adequate.

4)  Peter Cardinal's title is:  Director, Validation 

 

Feel free to contact me if you have any other questions.

 

Penny

 

Penny L. Post, PhD

Vice President, Regulatory and Quality

Protein Sciences Corporation

1000 Research Parkway

Meriden, CT  06450

Phone:  203-599-6064 X156

FAX:     203-599-6069

 