Links a CTD table-of-contents heading to the document(s) placed under it. Module 1 codes are regionally defined; Modules 2-5 are ICH-defined.
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HA Controlled Vocabulary
Controlled Vocabulary / Code System Name as defoined by the Health Authority
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Term
Term Description as defined by the Health Authority
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Code
Code, if any, associated with the term by the Health Authority
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Agency
Name of the issuing Health Authority (abbreviation) that maintains the term and code
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Status
Current status of the Term usage as defined by the Health Authority (e.g., Current, Retired, Deprecated)
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| US Context of Use | m1.14.2.3 final labeling text |
us_1.14.2.3
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FDA | — |
| US Context of Use | m1.14.3.1 annotated comparison with listed drug |
us_1.14.3.1
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FDA | — |
| US Context of Use | m1.14.3.2 approved labeling text for listed drug |
us_1.14.3.2
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FDA | — |
| US Context of Use | m1.14.3.3 labeling text for reference listed drug |
us_1.14.3.3
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FDA | — |
| US Context of Use | m1.14.4.1 investigational brochure |
us_1.14.4.1
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FDA | — |
| US Context of Use | m1.14.4.2 investigational drug labeling |
us_1.14.4.2
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FDA | — |
| US Context of Use | m1.14.5 foreign labeling |
us_1.14.5
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FDA | — |
| US Context of Use | m1.14.6 product labeling for 2253 submissions |
us_1.14.6
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FDA | — |
| US Context of Use | m1.15.1.1 request for advisory comments on launch materials |
us_1.15.1.1
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FDA | — |
| US Context of Use | m1.15.1.10 submission of annotated references |
us_1.15.1.10
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FDA | — |
| US Context of Use | m1.15.1.11 general correspondence |
us_1.15.1.11
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FDA | — |
| US Context of Use | m1.15.1.2 request for advisory comments on non launch materials |
us_1.15.1.2
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FDA | — |
| US Context of Use | m1.15.1.3 pre submission of launch promotional materials for accelerated approval products |
us_1.15.1.3
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FDA | — |
| US Context of Use | m1.15.1.4 pre submission of non launch promotional materials for accelerated approval products |
us_1.15.1.4
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FDA | — |
| US Context of Use | m1.15.1.5 pre dissemination review of televisions ads |
us_1.15.1.5
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FDA | — |
| US Context of Use | m1.15.1.6 response to untitled letter or warning letter |
us_1.15.1.6
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FDA | — |
| US Context of Use | m1.15.1.7 response to information request |
us_1.15.1.7
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FDA | — |
| US Context of Use | m1.15.1.8 correspondence accompanying materials previously missing or rejected |
us_1.15.1.8
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FDA | — |
| US Context of Use | m1.15.1.9 withdrawal request |
us_1.15.1.9
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FDA | — |
| US Context of Use | m1.15.2.1.1 clean version |
us_1.15.2.1.1
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FDA | — |
| US Context of Use | m1.15.2.1.2 annotated version |
us_1.15.2.1.2
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FDA | — |
| US Context of Use | m1.15.2.1.3 annotated labeling version |
us_1.15.2.1.3
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FDA | — |
| US Context of Use | m1.15.2.1.4 annotated references |
us_1.15.2.1.4
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FDA | — |
| US Context of Use | m1.16.1 risk management (Non-REMS) |
us_1.16.1
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FDA | — |
| US Context of Use | m1.16.2.1 final rems |
us_1.16.2.1
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FDA | — |
Showing 76–100 of 380 terms . Data sourced from public health authority publications and updated periodically.