AMCP Dossier Editorial Working Templates

What these are

These three dossier shells, available in Word and Markdown, and the Markdown instructions are original RWEdnesdays editorial working templates. They are designed to help a dossier team prepare a traceable draft and internal review packet without reproducing AMCP’s copyrighted Format. They do not substitute for the official AMCP Format 5.0, a payer’s instructions, an FDA communication assessment, or manufacturer legal/regulatory/compliance review.

When to use: choose the right shell

Use the Unapproved Product shell for A sections when initial FDA approval is being sought; use the Approved Product shell for B sections after FDA approval and an unsolicited HCDM request; use the Unapproved Use shell for C sections when a new use of an approved product is seeking FDA approval. The instructions file supplies the common evidence trace, projected-versus-current labeling, update/change-log, and conversion/retirement record. Check the official Format for exact required content and the current product, use, and communication status before drafting.

What it requires: evidence discipline

Each template separates a claim from its evidence, population, comparator, source/version, limitations, and reviewer. Keep ITC/NMA scope, network assumptions, and certainty visible. For payer economic work, identify model type, perspective, horizon, comparator, input source/version, validation, scenario analyses, and uncertainty; do not present a spreadsheet output as a conclusion without its assumptions. Keep predicted/pre-approval information visibly distinct from approved-label/current information.

How it maps to the catalog

Use AMCP Format for lifecycle selection, indirect comparison for the synthesis logic, and the protocol kit for generating the evidence behind a dossier exhibit.

Downloads

• Unapproved Product Dossier: Word · Markdown
• Approved Product Dossier: Word · Markdown
• Unapproved Use Dossier: Word · Markdown
• Instructions, evidence trace, and change-log template

When not to use them

Do not send an unreviewed working template externally. Do not treat completion as proof that a product claim, evidence synthesis, economic model, or communication is compliant. For final content requirements, use AMCP Format 5.0 and applicable organizational review.

Checklist

• Name the applicable official AMCP section, but use the official Format for exact requirements.
• Mark each statement and input as approved/current, projected/pending, or unavailable; do not collapse those states.
• Give every claim an evidence identifier and every model output an input/version/validation record.
• Record the communication pathway and required internal review before any external distribution.
• At a lifecycle transition, preserve the prior version, document conversion/retirement, and update the active dossier.

Citations

1. [1]AMCP Format for Formulary Submissions 5.0. Journal of Managed Care & Specialty Pharmacy. 2024;30(4-b Suppl):S1-S64.
2. [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. [3]Wang SV, Pottegård A, Crown W, et al. HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects. Pharmacoepidemiology and Drug Safety. 2023;32(1):44-55.