Record of Telephone Conversation, March 2, 2011 - Kedbumin

Submission Type: BLA    Submission ID: 125384/0    Office: OBRR
Product:
Albumin (Human)
Applicant:
Kedrion, S.p.A.
Telecon Date/Time: 02-Mar-2011 09:00 AM        Initiated by FDA? Yes
Telephone Number: -------(b)(4)--------
Communication Categorie(s):
1. Advice

Author: CRYSTAL ALLARD
Telecon Summary:
Discussion regarding pediatric study protocol. 
FDA Participants:
Crystal Allard, RAC
Laurence Landow, M.D.

Non-FDA Participants: 
Bruno Fiorentino, MD, Kedrion S.p.A.
--------(b)(6)-------, Kedrion S.p.A.
---------------(b)(4)----------------
------------------------(b)(4)-------------------
-----------(b)(4)--------------------

Telecon Body:

This discussion was in follow-up to a February 16, 2010 Telecon in which Kedrion was informed that they would have to complete a study of their product in pediatric patients.

Kedrion is working on their protocol now and intends to enroll 100 patients to study safety in the pediatric population aged 0-12 years. The draft protocol will be sent to FDA in March.

The protocol and accompanying cover letter should include the following information:
1.Pediatric age groups to be included in the study
2.Rationale for not studying the entire pediatric age group, from 0-16 years.
3.Projected dates of protocol finalization, initiation of enrollment, study completion, and submission of final clinical study report
4.Evidence that studies will be completed with due diligence by the agreed-upon date

Kedrion should understand that safety of the product in regards to renal function and blood loss is important to FDA.

Kedrion will likely perform the study in the U.S.
