FDA-specific form types referenced in Module 1 (e.g. Form FDA 356h, 1571). FDA-defined.
|
HA Controlled Vocabulary
Controlled Vocabulary / Code System Name as defoined by the Health Authority
|
Term
Term Description as defined by the Health Authority
|
Code
Code, if any, associated with the term by the Health Authority
|
Agency
Name of the issuing Health Authority (abbreviation) that maintains the term and code
|
Status
Current status of the Term usage as defined by the Health Authority (e.g., Current, Retired, Deprecated)
|
|---|---|---|---|---|
| US Form Type | Form FDA 1571: Investigational New Drug Application (IND) |
us_form_type_1
|
FDA | — |
| US Form Type | Form FDA 2252: Transmittal of Annual Reports for Drugs and Biologics for Human Use |
us_form_type_4
|
FDA | — |
| US Form Type | Form FDA 2253: Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use |
us_form_type_5
|
FDA | — |
| US Form Type | Form FDA 2567: Transmittal of Labels and Circulars |
us_form_type_6
|
FDA | — |
| US Form Type | Form FDA 3397: User Fee Cover Sheet |
us_form_type_3
|
FDA | — |
| US Form Type | Form FDA 356h: Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use |
us_form_type_2
|
FDA | — |
| US Form Type | Form FDA 3674: Certification of Compliance |
us_form_type_7
|
FDA | — |
| US Form Type | Form FDA 3792: Biosimilar User Fee Cover Sheet (BsUFA) |
us_form_type_8
|
FDA | — |
| US Form Type | Form FDA 3794: Generic Drug User Fee Cover Sheet (GDUFA) |
us_form_type_9
|
FDA | — |
| US Form Type | Form FDA 3938: Drug Master File |
us_form_type_11
|
FDA | — |
| US Form Type | Form FDA 3988: Transmittal of PMR/PMC Submissions for Drugs and Biologics |
us_form_type_10
|
FDA | — |
Showing 1–11 of 11 terms . Data sourced from public health authority publications and updated periodically.