Thank you for your continued support to reach this level of AI incorporation. The 21 CFR Part 312 - Investigational New Drug Application adaption was an important step towards Physical AI oncology clinical trial feasibility. The adaption maintains the prior regulation’s measures to protect both human subjects and data quality. Pharmaceutical manufacturers utilizing robotic systems would have to follow this regulation prior to new drug submission for human trials. At 94 pages, the pdf was a challenge, and ultimately had to be processed in a single conversation using two prompts across seven outputs by claude code due to full working memory issues. The original 21 CFR Part 312 document is in the public domain and may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license. This current work is not endorsed or sponsored by CFR.
Kevin Kawchak (Tue,) studied this question.