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Vaccines, Blood & Biologics
Submission Type: Original Application Submission ID: 125285/0 Office: OVRR
Protein Sciences Corporation
Telecon Date/Time: 06-OCT-2009 02:15 PM Initiated by FDA? Yes
Telephone Number: 203-599-6064
Author: TIMOTHY FRITZ
Dr. Penny Post was called to clarify some details of the September 24, 2009 face-to-face meeting with CBER.
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
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.