FDA-specific form types referenced in Module 1 (e.g. Form FDA 356h, 1571). FDA-defined.
| Term | Code | Agency | Status |
|---|---|---|---|
| Form FDA 1571: Investigational New Drug Application (IND) | us_form_type_1 | FDA | — |
| Form FDA 3988: Transmittal of PMR/PMC Submissions for Drugs and Biologics | us_form_type_10 | FDA | — |
| Form FDA 3938: Drug Master File | us_form_type_11 | FDA | — |
| Form FDA 356h: Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use | us_form_type_2 | FDA | — |
| Form FDA 3397: User Fee Cover Sheet | us_form_type_3 | FDA | — |
| Form FDA 2252: Transmittal of Annual Reports for Drugs and Biologics for Human Use | us_form_type_4 | FDA | — |
| Form FDA 2253: Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | us_form_type_5 | FDA | — |
| Form FDA 2567: Transmittal of Labels and Circulars | us_form_type_6 | FDA | — |
| Form FDA 3674: Certification of Compliance | us_form_type_7 | FDA | — |
| Form FDA 3792: Biosimilar User Fee Cover Sheet (BsUFA) | us_form_type_8 | FDA | — |
| Form FDA 3794: Generic Drug User Fee Cover Sheet (GDUFA) | us_form_type_9 | FDA | — |
11 terms shown across all authorities. Data sourced from public health authority publications and updated periodically.