Vaccines, Blood & Biologics
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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
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