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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, July 18, 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: 18-July-2011 14:00 PM        Initiated by FDA? Yes
Telephone Number: 858-292-1060
Communication Categorie(s):
1. Information Request

 
Author: JON DAUGHERTY
Telecon Summary:
Response to email from Allermed re: submission of product release protocol & samples
FDA Participants: Jon R. Daugherty, Ph.D.
Non-FDA Participants: Michael Durschlag
Trans-BLA Group: No

 
Related STNs: None
Related PMCs: None
Telecon Body:


 
I spoke with Mr. Durschlag regarding amendment number 16 to the BLA, submitted on July 15, 2011. I mentioned that the revised clean and red-lined versions of the PI document were submitted in column format with no line numbering. I requested that Allermed resubmit the documents on page format and with the line number, as was done for the Applicant’s response in the July 6, 2011 submission. I also asked that the revised documents be submitted in a font large enough to easily read for the purpose of review. If possible, we request that the tracked-changes editorial notations be shown at the end of the document rather than on the right side of the pages. This format will facilitate review of the documents. Mr. Durschlag said that Allermed will submit a copy of the revised PI in the requested format first via email and then within a few days as an official submission via the electronic gateway.