Module 1 (US) — Administrative Forms (OBX-319)
Document ID: M1-FORMS
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): 21 CFR 314/601
Administrative Forms — OBX-319
The regional administrative forms accompanying the OBX-319 application (Virtual Biopharma Inc.). Values are administrative placeholders in this mock; identifiers assigned by the authority at filing are shown as 'to be assigned'.
| Form | Purpose |
|---|---|
| FDA 1571 | Investigational New Drug Application |
| FDA 1572 | Statement of Investigator |
| FDA 356h | Application to Market a Biologic (BLA) |
| FDA 3454/3455 | Certification/Disclosure — Financial Interests of Investigators |
| FDA 3542/3542a | Patent Information |
| FDA 3397 | User Fee Cover Sheet (PDUFA) |
| FDA 3674 | Certification of Compliance (ClinicalTrials.gov) |
| Debarment certification | 21 U.S.C. 335a certification |
| Field copy certification | Certification of the field copy |
| Letters of Authorization | Cross-reference to Biologics/Drug Master Files |
21 CFR 601 (BLA); eCTD US regional 1.1-1.4.