Claims by status
1Prior approval expired
Claim C-011
One governed record per claim. Approved once with its risk information, then reused in every piece.
Claim record · Brand X (illustrative)
- Claim text
- [Outcome F] in patients previously treated with [drug class]
- Reference
- [Study 5] treatment-experienced cohort, Table [x]; PI Section 14.4
- Risk information
- ISI-01 · Brand X Important Safety Information (ISI) v3
- Status
- Prior approval expired
- Expiry date
- 30 Sept 2026
- Message strength
- 66Score from message testing (placeholder)
- Audience and channelProposed field
- HCP specialist · Sales aid, Leave-behind
- Treatment stageProposed field
- Treatment-experienced
Fair balanced claim — reviewed and approved as a pair
Claim C-011
[Outcome F] in patients previously treated with [drug class]
ISI-01
ApprovedBrand 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
- 30 Sept 2026 — Expiry date passed — Prior approval expiredMarketing ops coordinator
- 1 Aug 2026 — Marked Expiring in under 60 daysMarketing ops coordinator
- 30 Sept 2025 — Approved — expiry date setMarketing ops coordinator
- 15 Sept 2025 — Sent to review (Medical, Regulatory, Legal)Marketing ops coordinator
- 25 Aug 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.