Find the precedent before the agency does.
Approval precedents, label language and the evidence payers ask for, with every claim tied to a document.
| Drug | Pathway | Basis | Year |
|---|---|---|---|
| Resmetirom (Rezdiffra) | FDA accelerated approval | Histological endpoints at month 12 | 2024 |
Questions
The questions at this stage.
- Which drugs in this indication received accelerated approval, and on what surrogate?
- How do the labels of approved competitors describe efficacy?
- What evidence did HTA bodies ask for in recent appraisals?
- Which post-marketing requirements came with similar approvals?
Related use cases
Also at this stage.
The narrower questions teams bring to this stage.
Label comparison
Indication, dosing, warnings and efficacy language across competitor labels.
Approval precedents
Comparable approvals and the evidence they rested on.
HTA evidence dossiers
Literature tables for health technology assessment submissions.
Regulatory watch
New approvals, label changes and newly registered phase 3 trials as they appear.
Regulatory watch
Know when the landscape moves.
| Event | Detail | When |
|---|---|---|
| New indication | FDA approves a new obesity indication for tirzepatide | Week 1 |
| Label change | Cardiovascular warning updated against the prior version | Week 2 |
| New phase 3 | Oral GLP-1 registered in type 2 diabetes | Tracked |
Applications
What teams build.
Precedent search
Find comparable approvals and the evidence behind them.
Label comparison tools
Line up indication, dosing and warnings across competitors.
Evidence dossier builders
Assemble the literature tables an HTA submission needs.
Before your next agency meeting
Walk in with every precedent already found.
Comparable approvals, label language and the evidence behind them, cited to the document.