Dossier Claim-to-Evidence Matrix
An editable traceability matrix connecting exact proposed dossier wording to its evidence, uncertainty, limitations, lifecycle, permissions, review, and distribution context.
On this page
What this is
An evidence-to-wording working matrix that complements the AMCP dossier shells. Separate registers retain source records, exact proposed claims, claim support, population and effect details, conflicts, and review decisions. It is an original editorial aid, not an AMCP form or communication approval.
When to use
Use while drafting or updating a payer dossier, when a source changes, or at a product/use approval transition. Record the governing Format version and product/use status. In Format 5.0, A concerns an unapproved product, B an approved product, and C an unapproved use of an approved product for which FDA approval is being sought.
What it requires
Give every source and proposed statement stable IDs. Preserve population, comparator, endpoint, timepoint, estimate and uncertainty, source locator/version, limitations, and contradictory evidence. Assess whether each source supports the exact proposed wording, then separately record permissions, audience, channel, and human review status. Source credibility and authorization to communicate are different decisions.
Version check
The official AMCP page checked on October 14, 2026 still linked Format 5.0 and described a 6.0 update timeline. Recheck the maintained page before use. FDA's June 2026 payer-communication document was labeled draft and not for implementation; preserve its distinction from the 2018 final guidance and obtain the applicable organizational review.
When not to use
Do not infer permission, compliance, safety, effectiveness, or economic value from a completed matrix or a model's wording. Do not equate projected or investigational information with approved-label information. A review decision is limited to the recorded wording, version, audience, and use.
How it maps to the catalog
Pair with AMCP dossier templates, AMCP Format, and the ITC feasibility workbook when an indirect comparison supports a dossier exhibit.
Downloads
Word template · Markdown · Excel workbook · Build prompt · Review prompt
Model assistance
Complete kit ZIP · Instructions · Portable SKILL.md. Keep the folder together. Use the separate review prompt on the actual completed artifacts; the model must preserve missing facts and unapproved choices as unresolved.
Checklist
- Record the applicable Format version and exact product/use lifecycle status.
- Connect exact proposed wording to source version, population, comparator, result, uncertainty, and limitations.
- Distinguish factual source support from audience/channel permissions and organizational review.
- Record conflicts, expiry or update triggers, accountable reviewer, and scope of any clearance.
Citations
- [1]AMCP Format for Formulary Submissions 5.0. Journal of Managed Care & Specialty Pharmacy. 2024;30(4-b Suppl):S1-S64.
- [2]US Food and Drug Administration. Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities: Questions and Answers. Final Guidance for Industry and Review Staff. June 2018.
- [3]Academy of Managed Care Pharmacy. AMCP Format for Formulary Submissions. Maintained official resource page; accessed October 14, 2026.
- [4]US Food and Drug Administration. Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities: Questions and Answers. Draft Guidance for Industry. June 2026.