Module 1 (US) — Form 356h & Cover Letter (OBX-319)

Document ID: M1-356h
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): 21 CFR 314/601

FDA Form 356h & Cover Letter — OBX-319

Application to market a new drug/biologic for OBX-319 (sponsor Virtual Biopharma Inc.). The cover letter identifies the application type, the proposed indication (Systemic Lupus Erythematosus (moderate-to-severe active)), and the pivotal study OBX319-301; the 356h captures the administrative and establishment particulars. Application number to be assigned. 21 CFR 314/601; eCTD US regional.