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Obviously this was top-of-mind also because at the time they were putting the finishing touches on a draft guidance for industry entitled "Contents of a Complete Submission for the Evaluation of Proprietary Names" which was just released.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The draft guidance is open for comment for 60 days from the date it was published in the Federal Register.