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Vaccines, Blood & Biologics
Submission Type: BLA Submission ID: 125416/0 Office: null
Product: Pooled Plasma (Human), Solvent/Detergent Treated
Applicant: Octapharma Pharmazeutika Produktionsges.m.b.H.
Telecon Date/Time: 05-Nov-2012 09:00 AM Initiated by FDA? Yes
Telephone Number: -----(b)(4)-------
1. Other -
Author: PRATIBHA RANA
FDA Participants: Paul Mintz (via phone), Nisha Jain, Nancy Kirschbaum, Mitchell Frost, Pratibha Rana
Josef Weinberger, Corporate Quality and Compliance Officer
Michael Szkutta, Head of QA Plasma
Angelika Hurtl, Head of QA Plasma
Judy Smith, Octapharma Plasma, Inc. (OPI)
Monica Byrd, Octapharma Plasma, Inc. (OPI)
John DiAnn, Octapharma Plasma, Inc. (OPI)
Nancy Jensen, Octapharma Plasma, Inc. (OPI)
Stanley Ammons, Senior Director Government Policy & Corporate Compliance
Barbara Rangetiner, Director Int. Drug Regulatory Affairs
Sabine Ivancsits, Int. Drug. Regulatory Affairs Manager
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
FDA conveyed to the applicant that internal discussion with our experts and review of other applicable information resulted in FDA concurrence with Octapharma that implementing changes to require a second negative result for virus testing of Source Plasma donations before release of a previous donation would be burdensome. Therefore FDA accepts retention of Octapharma’s current controls for supply and release of Source Plasma for further manufacture into Pooled Plasma (Human), Solvent/Detergent Treated. In order to provide better safety assurance, however, FDA with require Octapharma to implement a pharmacovigilance plan as a PMR to capture the rate of viral transmission with their product. This will be additional to the two PMR’s already discussed.