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# Comments Sought on Pharma Quality/CMC Data Exchange
- URL: https://www.fdaweb.com/comments-sought-on-pharma-quality-cmc-data-exchange/
- Published: 2022-03-17T12:00:00.000Z
- Updated: 2026-09-14T17:36:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151388

*Federal Register* notice: FDA is seeking comments on its draft “Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange” for electronically submitting PQ/CMC data. The document provides a draft design of Health Level 7 (HL7) “Fast Health Interoperability Resources” (FHIR) profiles that contain the data elements and terminologies associated with submission. The agency says it cover only those concepts that are considered amenable to structuring and would bring value to the quality review process. The agency says it is seeking comment on the mapping of the PQ/CMC data elements to the various FHIR Resources. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-05790.pdf?ref=fdaweb.com).