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Monday, November 24, 2008

What's in a Name? The FDA's Got Yours.

At the ISCT-FDA Somatic Cell Therapy Symposium this Fall, there was much discussion about product nomenclature for cell therapies. It was a new subject for many in the audience.

CBER observed that several organizations in the sector are now laying the groundwork for setting standards in product nomenclature of HCT/Ps as a means of supporting and facilitating reimbursement, commerce, quality control (standards), labeling, etc. By asking that the session be included in the meeting, CBER wanted to ensure that such efforts were done in compliance with the product nomenclature framework that FDA already has in place.

Obviously this was top-of-mind also because at the time they were putting the finishing touches on a draft guidance for industry entitled "Contents of a Complete Submission for the Evaluation of Proprietary Names" which was just released.

For more background information, review Kim Benton's slides from the Somatic meeting. Darrin Weber also reviewed USP's efforts in putting together a product nomenclature monograph and Fran Rabe summarized ICCBA's efforts in applying the ISBT-128 labelling to human cells and tissue products. Click here for a link to these presentations (listed at the bottom of that page).

The guidance applies to proprietary name submissions for prescription drug products, including biologics, that are the subject of a new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics license application (BLA), or that are currently the subject of an investigational new drug application (IND) in anticipation of submission in a marketing application.

The FDA does not perform premarket name review or labeling review of HCT/Ps regulated under PHSA 361 .

The draft guidance is open for comment for 60 days from the date it was published in the Federal Register.


Alexey said...

thanks for link to presentations from the meeting,
didn't find anything particularly about "product nomenclature for cell therapies" in FDA draft tho

Lee Buckler said...


Look at the very bottom of the page

for the Product Nomenclature session and links to presentations by
Kimberly Benton, PhD
Darin Weber, PhD
Fran Rabe

Lee Buckler said...

FDA has also just published SOPP 8001.4 - Manual of Standard Operating Procedures and Policies
General Information - Review of CBER Regulated Product Proprietary Names, Version #2, dated November 24, 2008.

"This document describes the policies, procedures, and performance goals used in the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) for the review and evaluation of proposed proprietary names for biological products. These procedures are intended to ensure that the requirements set forth for proprietary name reviews under the Prescription Drug User Fee Act (PDUFA IV) in the Food and Drug Administration Amendments Act of 2007 (FDAAA) are met.

For products not covered by PDUFA, the procedures set forth in this document will be used; however, the performance goals will not apply. CBER will make every effort to respond to proprietary name reviews of non-PDUFA products as expeditiously as possible."