| Source | hl7.fhir.us.pq-cmc#current:PQ/CMC FHIR Implementation Guide (v5.0.0) |
| resourceType | ValueSet |
| id | pqcmc-stability-study-reason-terminology |
| canonical | http://hl7.org/fhir/us/pq-cmc/ValueSet/pqcmc-stability-study-reason-terminology |
| version | 0.1.15 |
| status | draft |
| publisher | HL7 International - Biomedical Research and Regulatory WG |
| name | PqcmcStabilityStudyReasonTerminology |
| title | Stability Study Reason Terminology |
| date | 2023-07-17T03:00:13+00:00 |
| experimental | true |
| description | Terminology used to qualify the information pertaining to stability study reason data in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. |
| jurisdictions | us |
| Usages |
|
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
| Code | Display |
| C115123 | Abbreviated New Animal Drug Application |
| C73113 | Abbreviated New Drug Application |
| C96089 | Annual Report |
| C96094 | Supplement to an Approved Application |
| C71778 | Biologics License Application |
| C70877 | Master File |
| C115122 | Generic Investigational New Animal Drug File |
| C80440 | Humanitarian Device Exemption (HDE) |
| C82667 | Investigational Device Exemption |
| C96091 | Investigational New Animal Drug File |
| C96090 | Investigational New Drug Application |
| C96092 | New Active Ingredient |
| C72901 | New Animal Drug Application |
| C72899 | New Drug Application |
| C70880 | Premarket Approval |
| C80442 | Premarket Notification 510(K) |
Produced 08 Sep 2023