Regulatory Correspondence, published by Gravitate Health and HL7 Vulcan. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/rfi-ig/ and changes regularly. See the Directory of published versions
Example Bundle: rfi-bundle-003
Bundle rfi-bundle-003 of type collection
Entry 1
Resource Communication:
RFIDueDate: 2025-07-15 23:59:59+0000
basedOn: MedicinalProductDefinition/NDA78901
status: In Progress
category: RFI
recipient: Organization/MAH-PharmaCorp
sender: Organization/FDA
Payloads
Content[x] Bundle: type = collection
Entry 2
Resource Questionnaire:
LinkID Text Cardinality Type Description & Constraints 
Questionnaire q1
Provide details on the drug product packaging. 0..1 group q1.1
**Packaging Details**: Describe the primary packaging materials and their compatibility with the drug product. 0..1 display q1.2
Upload an image of the packaging. 0..1 attachment Provide any additional notes on packaging stability or testing. 0..1 display Documentation for this format
