Record of Telephone Conversation, October 16, 2012 - Octaplas
Submission Type: BLA Submission ID: 125416/0 Office: OBRR
Product: Pooled Plasma (Human), Solvent/Detergent Treated
Applicant: Octapharma Pharmazeutika Produktionsges.m.b.H.
Telecon Date/Time: 16-Oct-2012 11:00 AM Initiated by FDA? No
Telephone Number: -------(b)(4)-----------
Author: PRATIBHA RANA
Telecon Summary: Clarification on Major Amendment Designation
Participants from Octapharma:
Wolfgang Frenzel, International Medical Director
Jürgen Römisch, Senior Vice President R&D Plasma
Josef Weinberger, Corporate Quality and Compliance Officer
Stanley Ammons, Senior Director Government Policy & Corporate Compliance
Johnny Abi Haidar, Project Manager
Barbara Rangetiner, Director Int. Drug Regulatory Affairs
Simone Meindl, Int. Drug. Regulatory Affairs Manager
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Octapharma requested this teleconference with FDA to clarify the e-mail notification sent to the Applicant on Friday October 12, 2012, designating STN 125416/0.12 as a major amendment.
FDA clarified that complete review of STN 125416/0.12 and negotiations regarding content of the Full Prescribing Information (FPI, product label) justify the 3 month extension of the action due date. Octapharma concurred. FDA will work actively with Octapharma and make every effort to complete the review and resolve all issues before the 21 January 2013 action due date.
FDA also addressed the issue of ---(b)(4)--- inventory hold for Source Plasma. FDA informed Octapharma that our expert staff has been consulted for options regarding software control of inventory to ensure release of Source Plasma units for which a second negative test is available.
Revised/ Nancy Kirschbaum/ 10-17-2012
Reviewed/ Mitchell Frost/ 10-17-2012