iZO Promo Review
Fictional brands · Sample data as of 12 Oct 2026
Claims by status
1Modified from approved

Claim C-006

One governed record per claim. Approved once with its risk information, then reused in every piece.

Claim record · Brand X (illustrative)

Claim text
[Outcome D] maintained through Week 104 in [Study 3] extension
Reference
[Study 3] open-label extension, Table [x]; PI Section 14.3
Risk information
ISI-01 · Brand X Important Safety Information (ISI) v3
Status
Modified from approved
Expiry date
10 Feb 2027121 days from 12 Oct 2026
Message strength
64Score from message testing (placeholder)
Audience and channelProposed field
HCP specialist · Email, Sales aid
Treatment stageProposed field
Long-term maintenance

What changed since approval

Approved wording

[Outcome D] maintained through Week 52 in [Study 3]

Current wording

[Outcome D] maintained through Week 104 in [Study 3] extension

Removed words are struck through; added words are highlighted and bold.

Fair balanced claim — reviewed and approved as a pair

Claim C-006

[Outcome D] maintained through Week 104 in [Study 3] extension

ISI-01

Approved

Brand X Important Safety Information (ISI) v3

[Boxed warning, contraindications, warnings and precautions, most common adverse reactions — approved ISI text placeholder]

Shown with the claim in every pieceStored once, linked to 10 claims. Terms vary by company: ISI, IRI or fair balance language.

Status

New
Review
Approved
● Modified
Expiring <60 days
Prior approval expired
FDA removed
Sign-off:

Status history

  1. 5 Oct 2026 — Label update LBL-2026-01 — moved to Modified from approved, sent to review queueMarketing ops coordinator
  2. 10 Feb 2026 — Approved — expiry date setMarketing ops coordinator
  3. 28 Jan 2026 — Sent to review (Medical, Regulatory, Legal)Marketing ops coordinator
  4. 12 Jan 2026 — Created as New, reference attachedMarketing ops coordinator

Used in pieces (1)

Design rules

  • Smallest approvable unit — if two claims must always appear together, they become one claim.
  • Risk information stored once — fair balance and safety language is linked to claims, not copied.
  • One record, many pieces.

What moves a status

  • • Expiry date approaching or passed
  • • Label updates: new data, indications, boxed warnings, monitoring
  • • FDA actions
  • • Removal letters

Every return to Approved passes through Medical, Regulatory and Legal.