Claims by status
1New
Claim C-010
One governed record per claim. Approved once with its risk information, then reused in every piece.
Claim record · Brand X (illustrative)
- Claim text
- Lower [event] rate vs [comparator] in [Study 4]
- Reference
- [Study 4] safety analysis, Table [x]; data on file
- Risk information
- ISI-01 · Brand X Important Safety Information (ISI) v3
- Status
- New
- Expiry date
- (not set)
- Message strength
- 61Score from message testing (placeholder)
- Audience and channelProposed field
- HCP specialist · Sales aid
- Treatment stageProposed field
- Comparative
Fair balanced claim — reviewed and approved as a pair
Claim C-010
Lower [event] rate vs [comparator] in [Study 4]
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
- 7 Oct 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.