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How to Automate FDA Regulatory Document Generation with Claude and Streamlit

Learn how to prototype and build a production-ready application to automate the creation of massive FDA submission documents. This workflow takes you from a simple prompt in Claude to a functional Streamlit app with features like PHI redaction and cost analysis.

From How I AI

How Prerna Kaul Automates 60,000-Page FDA Submissions and Coaches PMs with AI

with Claire Vo

How to Automate FDA Regulatory Document Generation with Claude and Streamlit

Tools Used

Claude

Anthropic AI assistant

Step-by-Step Guide

1

Prototype with Claude as Your Co-founder

Treat Claude as a software engineer collaborator. Provide a high-level prompt outlining the problem, business impact, and desired outcome to generate a complete project plan, including step-by-step instructions, core capabilities, a demo script, and starter Python code.

Prompt:
The thinking I had in mind is that Claude is a software engineer, and I'm talking to them and trying to tell them why it matters like any good PM would, and trying to tell them what end product we wanna produce as a result.
2

Build Core Logic for PHI Redaction

Instruct Claude to build the logic for detecting and redacting Protected Health Information (PHI) from unstructured clinical data. It can identify the correct models for medical named entity recognition and generate the necessary Python code and complex RegEx for pattern matching.

3

Develop a User-Friendly UI with Streamlit

Wrap your Python script in a simple user interface using the Streamlit framework to make the tool accessible to non-technical colleagues. You can run the application locally from your terminal to quickly spin up a web app.

Prompt:
streamlit run app.py
4

Implement Document Generation and Export

Add functionality to the app that summarizes the cleaned clinical trial data into the required Common Technical Document (CTD) format. Crucially, include options to download the output as both a standard text file and the proprietary XML format required for official submissions.

5

Integrate Cost Analysis for Stakeholder Buy-in

Build a feature directly into the app that tracks the token cost and duration for each operation (e.g., PHI redaction, document generation). This provides transparent data on the tool's ROI, making it easier to gain approval from stakeholders by directly comparing AI costs to manual processes.

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