Module 1.0 — Administrative Documents Index (OBX-319)

Document ID: M1-0
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): eCTD regional

1.0 Administrative Documents Index — OBX-319

This index lists the regional administrative content for the OBX-319 marketing application (sponsor Virtual Biopharma Inc.). It covers the cover letter, application forms, the prescribing information/labeling, the risk-management plan, and patent/exclusivity and fee forms, as required by the receiving authority. Study identifier: OBX319-301.