Claims by status
1Expiring in under 60 days
Claim C-004
One governed record per claim. Approved once with its risk information, then reused in every piece.
Claim record · Brand X (illustrative)
- Claim text
- [Outcome C] in patients with [subgroup] in [Study 2]
- Reference
- [Study 2] prespecified subgroup analysis, Table [x]; PI Section 14.2
- Risk information
- ISI-02 · Brand X Important Risk Information (IRI) — HCP short form v2
- Status
- Expiring in under 60 days
- Expiry date
- 18 Nov 202637 days from 12 Oct 2026
- Message strength
- 68Score from message testing (placeholder)
- Audience and channelProposed field
- HCP specialist · Sales aid
- Treatment stageProposed field
- Special populations
Fair balanced claim — reviewed and approved as a pair
Claim C-004
[Outcome C] in patients with [subgroup] in [Study 2]
ISI-02
ApprovedBrand X Important Risk Information (IRI) — HCP short form v2
[Condensed IRI placeholder for digital/short-form use]
Shown with the claim in every pieceStored once, linked to 2 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
- 19 Sept 2026 — Marked Expiring in under 60 days — added to review queueMarketing ops coordinator
- 18 Nov 2025 — Approved — expiry date setMarketing ops coordinator
- 27 Oct 2025 — Sent to review (Medical, Regulatory, Legal)Marketing ops coordinator
- 6 Oct 2025 — 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.