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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Lot Release Protocol Revisions Email, July 8, 2011 - Anascorp

From:                     Fisher, Robert

Sent:                      Friday, July 08, 2011 6:03 PM
To:                         'jspinella@raretx.com'
Cc:                         Cordaro, Debbie
Subject:                 BLA STN 125335/0 Lot Release Protocol revisions
 
Attachments:        Licensing Sample template letter 061711.doc; Lot Release Protocol Template Basic.pdf
 
Dear Ms. Spinella:
 
A draft lot release protocol was submitted to this file on 17 April 2009. Since the specifications for Anascorp have been modified during the ongoing review process, please revise the protocol to reflect the most recent lot release specifications. In addition, please submit 5 vials of each conformance lot to the following address:
 
Sample Custodian (ATTN: HFM-672)
Center for Biologics Evaluation and Research
Bldg: NLRC-B, Room: 113
5516 Nicholson Lane
Kensington, Maryland 20895
 
The samples should be accompanied by a Letter for Licensing Sample Submission, and their respective Lot Release Protocols. Templates for each are enclosed for your reference.
 
(Licensing Sample Template and Lot Release Protocols Template)
 
Robert W. Fisher, Ph.D.
Staff Fellow, Laboratory of Plasma Derivatives
FDA/CBER/OBRR/DH
202-329-3957
Robert.Fisher@fda.hhs.gov