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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, August 2, 2011, Anascorp

 

Submission Type: BLA    Submission ID: 125335/0    Office: OBRR
Product:
Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection
Applicant:
Rare Disease Therapeutics, Inc. (RDT)
Telecon Date/Time: 02-Aug-2011 12:10 PM        Initiated by FDA? Yes
Telephone Number: (619) 328-5370
Communication Categorie(s):
1. Other - Post Marketing Commitments
 
Author: DONALD ERTEL
Telecon Summary:
PMC follow-up
FDA Participants: Donald Ertel
Non-FDA Participants: RDT: Jennifer Spinella
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:

RDT submitted the draft of the PMCs and written commitments discussed in the teleconference on 08/02/11@ 11:30am. 
Discussion: We found the content, and expected completion of Dec 31, 2011 to be acceptable. 
I stated that we expect to see --------------------(b)(4)-----------------------------.
RDT stated that they will submit an amendment to the submission for the PMCs and written commitments today, 08/02/11. 
Call ended 12:20 PM