The PQ/CMC Data exchange standard is intended to be developed as Health Level 7 (HL7) Fast Health Interoperable Resources (FHIR) representation. The project has been established with the HL7 Biomedical Research & Regulation (BR&R) work group and discussions regarding representing the PQ/CMC structured elements in FHIR occur during the work group meetings.
These HL7 BR&R WG meetings are open to the public. To see the agenda for the meetings and learn more, go to https://confluence.hl7.org/display/BRR
- For additional information/support from PQ/CMC Team, please contact PQ-CMC@fda.hhs.gov.