Claims by status
1Modified from approved
Claim C-008
One governed record per claim. Approved once with its risk information, then reused in every piece.
Claim record · Brand X (illustrative)
- Claim text
- No dose adjustment needed for [population]
- Reference
- PI Section 2.[x] Dosing in specific populations; Section 8.[x]
- 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
- 55Score from message testing (placeholder)
- Audience and channelProposed field
- HCP and pharmacist · Leave-behind
- Treatment stageProposed field
- Dosing
What changed since approval
Approved wording
No dose adjustment needed for most patients
Current wording
No dose adjustment needed for [population]
Removed words are struck through; added words are highlighted and bold.
Fair balanced claim — reviewed and approved as a pair
Claim C-008
No dose adjustment needed for [population]
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
- 5 Oct 2026 — Label update LBL-2026-01 — moved to Modified from approved, sent to review queueMarketing ops coordinator
- 10 Feb 2026 — Approved — expiry date setMarketing ops coordinator
- 28 Jan 2026 — Sent to review (Medical, Regulatory, Legal)Marketing ops coordinator
- 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.