Comment from eSTARHelper LLC

We believe our ‘dueling banjo’ strategy app made up of (1) part AI/ML drive & (2) part-Human FDA.Gov full text regulatory search working in tandem from a single UI/UX screen app interface is ONE ANSWER. This approach aligns well with the Guidance reference to "human in the loop' which in our case provides a risk-based credibility assessment framework that may be used for establishing & evaluating the credibility of an AI model for a particular context of use (COU). The articles PDFs cited below were jointly prepared by a team that includes former US FDA Deputy Director Dr. Ajaz Hussain and myself Ram Balani, CEO-Founder of eSTARHelper. https://tinyurl.com/4f8jfhtn https://tinyurl.com/99fddahb eSTARHelper LLC is a Microsoft for Start-up Founders Hub member company and developer of our Microsoft FDA AI/ML Copilot (ChatGPT-4 Azure instance) integrated with eSTARHelper’s unique SmartSearch+ - where You-the-Human can full text search ACTUAL FDA.Gov Guidance PDFs and 21 CFRs on drugs (CDER), biologics (CBER) and medical devices (CDRH) – all in one app screen. We would appreciate feedback or comments at your convenience. Additionally specific podcast for each PDF article above were generated via Notebook LLM tool. https://tinyurl.com/4vfnvmby https://tinyurl.com/s79uzmpt FYI: The AI/ML FDA Copilot is hosted at: www.estarhelper.com/FDACopilot -- just point & click, no account set-ups required nor app store downloads or credit cards, i.e. full anonymous browser access. Enter ‘smartsearch’ (no quotes) on the bot message field to gain full guest user access to SmartSearch+