Regulatory and promotional review
Find hard-to-read risk text before it reaches MLR
FDA's ad office, OPDP, had posted 61 letters by late October 2025, and many cite risk text that is hard to read. HealthLiteracyCopilot checks reading level, sentence length and plain wording in each risk statement before MLR. Protected terms stay word for word. Every change, review and sign-off stays on record.
For regulatory affairs, labeling, promotional review and MLR leads
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What you check first
Risk text checked before MLR sees it
- Reading level, sentence length and plain wording in each risk statement.
- Protected terms and approved disclaimers kept word for word.
- Each decision and e-signature on an append-only audit trail.
Illustrative example, with a synthetic portrait.
What you're measured on
Open a measure to see why it matters and how HealthLiteracyCopilot helps.
OPDP letters that cite risk text
- Why it matters
- OPDP sent 5 letters a year in 2023 and 2024, then had posted 61 by late October 2025. Many cite risk text that is hard to read or easy to misread.
- How HealthLiteracyCopilot helps
- Each risk statement is checked for reading level, sentence length and plain wording before it goes to MLR. Your reviewers see each change and the reason for it.
We don't promise fewer letters. Your regulatory team decides what goes out.
Patient Medication Information (PMI) readiness
- Why it matters
- FDA's regulatory agenda lists the PMI final rule for December 2026. It would replace Medication Guides and patient package inserts with one patient-facing page in a set format, so outpatient prescription drugs, brand and generic, would need new patient labeling.
- How HealthLiteracyCopilot helps
- Medication guides are written to a target grade from your approved labeling. Protected terms and approved wording stay word for word, and each reviewer's decision is recorded.
The rule is not final, and its format may change. Your labeling team decides what is submitted.
MLR review rounds
- Why it matters
- A piece that comes back for clarity issues goes through medical, legal, regulatory and safety review again.
- How HealthLiteracyCopilot helps
- Clarity issues are flagged before MLR starts. Reviewers work in series or in parallel, and each decision is recorded.
We don't promise fewer rounds or a cycle time. Count your rounds before and after and see for yourself.
Audit trail
- Why it matters
- When someone asks who approved a piece, which version and when, the answer has to be on record.
- How HealthLiteracyCopilot helps
- Part 11-style e-signatures and an append-only audit trail keep each version, decision and sign-off. A release gate comes before the hand-off to Veeva.
The record shows what was reviewed and signed. Whether your process meets a regulation is a question for your quality and legal teams.
Why plain language matters here
57%
of Medicare enrollees had Basic or Below Basic health literacy
Start this week
What you can hand your team this week
A 60-second risk-text check
Paste approved public risk information. See its reading level and the passages to fix first.
Open itYour review workload
Put a number on the reviewer hours each round takes, from your own inputs.
Open itTry one piece free
Send one approved public patient document. It comes back with the changes to make and the reason for each one.
Open it
The documents you own
| Document | What it touches |
|---|---|
| DTC risk information for web, print, social and video scripts | Reading level and plain wording |
| Medication guides and patient information | Plain wording in risk statements |
| Patient-support and REMS materials | Clear steps and warnings |
| Protected terms and approved disclaimers | Kept word for word |
What you'd use most
Risk-text scoring
Reading level, sentence length and plain wording, checked in each risk statement.
Learn moreMLR review and e-signatures
Medical, legal, regulatory and safety reviewers in series or in parallel, with Part 11-style e-signatures.
Learn moreProtected terms and approved disclaimers
Product names, safety language and approved disclaimers stay word for word.
Learn more
Try it on one of your documents
Send a blank template, not a copy with a patient's or member's details.
Questions
Does this replace MLR review?
No. It prepares materials before MLR review. Your medical, legal, regulatory and safety reviewers decide, and each decision is recorded.
Does it change safety language?
No. Protected terms and approved disclaimers stay word for word, and the meaning check flags any change for your reviewers.
Do you need patient data?
No. Send approved public material or a blank template, never a patient's details.