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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email, April 19, 2012 - ALLOCORD

 

From:                                       Tull, Lori
Sent:                                        Thursday, April 19, 2012 1:54 PM
To:                                            'Donna Regan'
Subject:                                   Need NDC number and formal request for AlloCORD tradename
 
Hi Donna,
 
Just a reminder that we need your official tradename request. 
 
Also, my apologies if you already are working on this but if not, you need to apply for an NDC number since you are not using ISBT128.
 
 The elements that make up the NDC number are the firm labeler code, product code, and package size code. There is not an element for diff manufacturing sites under the same firm. 
http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm):
 
Each listed drug product is assigned a unique 10-digit, 3-segment number. This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug. The second segment, the product code, identifies a specific strength, dosage form, and formulation of a drug for a particular firm. Different formulations or different strengths of the same formulation should be assigned different product codes. This means even if the same formulations of a drug product ultimately deliver different strengths of the active ingredient to the recipient, they should be assigned different product codes. Also, drug products that share the same formulation but have different product characteristics that clearly distinguish one drug product version from another can not share the same product code under the same labeler code. The third segment, the package code, identifies package sizes and types. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging. Both the product and package codes are assigned by the firm. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.
 
______________________________________________
From:                    Tull, Lori 
Sent:                      Friday, March 30, 2012 11:25 AM
To:                         'Donna Regan'
Subject:                 Need responses to info requests and formal request for AlloCORD tradename
 
Hi Donna,
 
We noticed that you have the name AlloCORD in your labeling, but we need an official request for that to be reviewed as the tradename. I have included the guidance that may be of some assistance.
 
 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075068.pdf
 
Also, we have sent requests for information for which we are awaiting your response (submission). We just want you to be aware that we need to receive your responses as soon as possible in order to complete the review of the BLA. Responses received after May 20 could constitute a major amendment, which would extend our review clock 3 months past the current August 20 due date.
 
Best Regards,
Lori
 
Lori A. Tull, RAC
Regulatory Project Manager
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research
(301) 827-5359
 
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