Understanding FDA §1114.7: What a PMTA-Ready Report Must Contain
Answers: “FDA §1114.7 report template / format”
21 CFR §1114.7 defines the content and format of a Premarket Tobacco Product Application. A "PMTA-ready report" is one drafted the way an FDA reviewer reads it — structured to the section, with traceable evidence.
What a §1114.7-aligned evidence package includes
- Health-risk / toxicology evidence (§910(b)) — e.g., ELCR from HPHCs, benchmarked to 1R6F.
- Pharmacokinetics (§910(b)) — Cmax/Tmax/AUC with prediction intervals.
- Population health impact (§910(c)(4)) — PDA/LYG with sensitivity analysis.
- Traceable citations — 14–21 references per report so every number can be sourced.
- Language — a professional, all-English report (no mixed-language text in the document), even when the applicant works bilingually.
Pros vs. cons. Pro: a report pre-formatted to §1114.7 with sourced numbers reduces reviewer friction at the acceptance and filing stage. Con: format compliance is necessary but not sufficient — the underlying science and confirmatory data still determine substantive review.
Who should NOT buy: teams with an established regulatory writing function already producing §1114.7-formatted outputs and full confirmatory datasets.
FAQ
What format does the report ship in?
A paginated, submission-format report (print-to-PDF + HTML) with a scenario JSON record and full citations.
Is the deliverable bilingual?
Guidance and inputs are bilingual (中文/English); the deliverable report is all-English.
See your formula’s evidence today
Run ELCR, in-silico PK and PHIA in your browser — a §1114.7-ready report in hours.
Start free — no signup