
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)-----------

Communication Categorie(s):

1. Advice

Author: PRATIBHA RANA

Telecon Summary: Clarification on Major Amendment Designation

 

FDA Participants:

 

Basil Golding

Paul Mintz

Nisha Jain

Nancy Kirschbaum

Mitchell Frost

Pratibha Rana

 

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

 

Telecon Body:

 

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.

 

END.

 

Revised/ Nancy Kirschbaum/ 10-17-2012

Reviewed/ Mitchell Frost/ 10-17-2012