AI drafting and QC in Microsoft Word
US Prescribing Information
Carry approved core content into the FDA Physician Labeling Rule format, section by section, in Microsoft Word. Values the sources do not give are marked [MISSING] for your team to supply.
See USPI drafted in Word
A short demo on a fictitious study and product. In a live demo we walk through the same workflow and answer your questions about sources, review and deployment.
Read the transcript
US prescribing information carries your core safety data into the FDA format, section by section. PharmAssist works inside Word. Choose the document type and add your source files. It lays out the document's outline, right in Word. Pick a section, and PharmAssist drafts it from your sources. Review the draft, then insert it into your document. You can also ask questions in chat. Answers come from your own files, and show which ones they used. From your sources to a draft in Word, ready for expert review. Book a demo at gentext.ai/pharma.
What to check in the draft
- Check the version and effective date of each source file before you rely on a draft or a chat answer.
- Compare renal and hepatic dose adjustments in section 2 with section 4 Contraindications and the renal and hepatic impairment subsections of section 8.
- Confirm that each Highlights statement is supported by the Full Prescribing Information.
- Read every [MISSING] marker and every number the Checks panel flags against the CCDS before you insert the text.
Can AI help draft US Prescribing Information?
Yes, as a drafting and checking aid. PharmAssist takes your company core data sheet and approved clinical and safety sources, lays out the PLR structure in Word, and drafts selected Full Prescribing Information sections from mapped source sections. The pane lists the files used for the draft and displays candidate source passages where it finds a match. Review those passages against the original source. It flags missing inputs and numbers that do not appear in the sources. Approval stays with your regulatory team.
How this document gets written today
A USPI update usually starts with a CCDS change, a new safety signal or a supplemental application. The labelling lead then has to carry that change through Highlights, the Full Prescribing Information and every section that cross-references it, while keeping wording consistent with FDA conventions and the company style.
Most of the effort goes into checking: does section 2 match the dose in the CCDS, does section 5 reflect the current safety position, are the Highlights limited to what the full text supports. A fluent paragraph is not useful if nobody can see where it came from.
What your team can work on
Structure follows the PLR format described in 21 CFR 201.56 and 201.57, with your sponsor template and conventions.
PLR section drafts
Draft Full Prescribing Information sections such as 2 Dosage and Administration, 5 Warnings and Precautions and 6 Adverse Reactions in the PLR order, using your template and house wording.
Cross-section review
For a USPI, review dose limits in section 2 against section 4 Contraindications and section 5 Warnings and Precautions, so a CCDS change reaches every section that depends on it.
Highlights review
The terminology check looks for the required Highlights heading and standard FDA terms. Your labelling team confirms that each Highlights statement is supported by the full prescribing information.
Missing and unsupported content flags
Values that are absent from the sources are marked as missing, and numbers that do not appear in the sources are flagged for review rather than accepted.
How it works for USPI
Choose USPI
Select US Prescribing Information as the document type and confirm the sections in scope for this update.
Add the sources
Upload the CCDS, the current USPI and the approved clinical and safety sources. PharmAssist maps each label section to the source sections it should draw from.
Draft by section
Draft a section, work through the Checks panel, and ask questions of your own files in chat.
Review and insert
Insert the reviewed text into your Word document and continue through your normal labelling review and approval.
What it drafts from
Select the approved sources for the task. Data handling follows the deployment and model-service configuration agreed with your team.
- Company Core Data Sheet (CCDS)
- Current USPI and revision history
- Approved clinical and safety sources
- Sponsor labelling template and style conventions
What stays with your team
PharmAssist supports your document workflow. Interpretation, medical and regulatory judgement, approval and submission stay exactly where they are today, with qualified people and your existing review chain.
Choose GenText-hosted SaaS or a private deployment. Confirm access, data handling, model services and retention during supplier qualification.
Security and deployment detailQuestions we are asked about this document
Does PharmAssist follow the PLR format?
The outline uses the PLR structure. PharmAssist drafts selected Full Prescribing Information sections from mapped source sections; your team prepares and reviews Highlights and confirms the final content and format.
Can it update an existing USPI after a CCDS change?
Yes. Add the revised CCDS and the current USPI as sources, then draft the affected sections and review them against the revised CCDS before you insert them.
What happens when the source does not contain a value?
The draft marks it [MISSING] for your team to supply. The Checks panel lists missing inputs and flags numbers in the draft that do not appear in the sources. Read each value before you rely on it.
Who reviews and approves the USPI?
Your qualified specialists do. PharmAssist drafts and checks; scientific interpretation, medical and regulatory judgement, quality review and approval stay with your team and your existing review chain. Open questions and missing inputs stay visible in the draft until a person resolves them.
Does PharmAssist work inside Microsoft Word?
Yes. PharmAssist is a Microsoft Word add-in for Windows, Mac and Word on the web. You choose the document type, add your source files, review the outline and section drafts in a side pane, and insert approved text into the document you are already working on.
Where does our data go, and do we need a Veeva connection to begin?
Choose GenText-hosted SaaS or a private deployment. Data handling, model services and retention are confirmed with your technical owner during supplier qualification. A demonstration starts with fictitious documents and upload; connections to Veeva Vault or other source systems are scoped during implementation.
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Talk to us about USPI
Tell us your role, source material and next document milestone. We will confirm the demonstration scope and define a paid pilot with your team.
Prefer email? alex@gentext.ai