
Record of Telephone Conversation, June 27, 2011 - Spherusol

 
 
Submission Type: BLA    Submission ID: 125354/0    Office: OVRR
Product:
Coccidioides immitis Spherule-Derived Skin Test Antigen
Applicant:
Allermed Laboratories, Inc.
Telecon Date/Time: 27-Jun-2011 02:25 PM        Initiated by FDA? Yes
Telephone Number: 858-292-1060
Communication Categorie(s):
1. Information Request

 

Author: JON DAUGHERTY

Telecon Summary:

I called Dr. Nielsen regarding the revised Debarment Certificate.

FDA Participants: Jon R. Daugherty, Ph.D.

Non-FDA Participants: H.S. Nielsen, Jr., Ph.D.

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

Telecon Body:



I called Dr. Nielsen to inform him that we can't find the revised Debarment Certificate in the June 16, 2011 submission to the BLA. Dr. Nielsen thought that the revised certification had been submitted, but he will check to see if this was the case.