One product, three teams, one change log
Real sources · Illustrative request · Sample version
Customer question
A fictional medicine team with an established baseline maintains five questions for one indication.
Do this month’s sources affect existing claims, or can we record no detected change?
Change reports explain claim impact and unresolved checks. A scan without new evidence still retains a search record.
From scan to shared version
| Check / stage | Chart content |
|---|---|
| Baseline v1 | Five questions, evidence cutoff and existing claims |
| Scan 01 | Assume one candidate source; claim impact not yet determined |
| Professional review | Check population, results and corrections; flag unresolved items |
| Quarterly version v2 | Affected claims, unchanged questions and next triggers |
This illustrates a change log, not an actual product-label revision. Annual allowances follow the existing package.
Analysis excerpt
| Check | Finding / sample content | Use |
|---|---|---|
| Candidate source | “Newly published” and “changes the conclusion” are separate fields | Review and mark included, excluded or unresolved |
| No change detected | Retain databases, searches, date and scan results | Explain coverage in the quarterly report without inventing findings |
Delivery manifest
| File | Format | Contents |
|---|---|---|
| shared-evidence-index.xlsx | XLSX | Shared index for five agreed questions with sources and versions. |
| quarterly-change-report.pdf | Quarterly changes, no-change findings, unresolved checks and claim impact. | |
| annual-scan-log.csv | CSV | Dates, search versions, candidates and review status for 12 scans. |
This is an illustrative formal delivery manifest. This pack supplies an HTML report, CSV tables and a source register. Agree formal formats, quantities and scope in the quote.
Acceptance criteria
- Each update records the baseline, changes, sources and review status. Scans with no new studies record no detected change rather than manufacture new findings.
Sources
- FDA: Prescribing Information Resources
https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/prescribing-information-resources