> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Comments Sought on Pharmaceutical Quality Terminology
- URL: https://www.fdaweb.com/comments-sought-on-pharmaceutical-quality-terminology/
- Published: 2024-10-07T12:00:00.000Z
- Updated: 2026-09-14T14:43:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157930

FDA is requesting comments on a draft document about controlled terminology/vocabulary that applies to a set of coded quality attribute data elements and their categorization for therapeutic protein products. “Since the content of this chapter is part of the early thinking of CDER’s Office of Pharmaceutical Quality (OPQ) which may ultimately be incorporated for use in development of Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminology, we are presenting this as ‘Informational Chapter A,’” an [agency notice](https://lnks.gd/l/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvaW5kdXN0cnkvcGhhcm1hY2V1dGljYWwtcXVhbGl0eS1jaGVtaXN0cnktbWFudWZhY3R1cmluZy1jb250cm9scy1wcWNtYy9wcWNtYy1mZWRlcmFsLXJlZ2lzdGVyLW5vdGljZXM%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5IiwiYnVsbGV0aW5faWQiOiIyMDI0MTAwNy4xNDk2MjQxIn0.2m9LE%5FNmDARfanzhQnTd5utrHTkeRB3MX4-NuUpnVZs/s/1255720147/br/250501395759-l?ref=fdaweb.com) says.

The document can be downloaded [here](https://www.fda.gov/media/182387/download?attachment&ref=fdaweb.com), and the open docket for public comment is [here](https://www.regulations.gov/document/FDA-2023-N-1443-0001?ref=fdaweb.com). FDA says comments should be submitted by 12/5.