As a life science professional, understanding the regulatory and ethical implications of AI-based inventions is crucial. Recognizing issues related to accountability and ensuring quality, safety, and fair usage in product creation are essential. The Food and Drug Administration (FDA) recognizes AI as a valuable tool in the innovation process and is actively involved in ensuring these smart technologies meet quality and safety standards. 

In this context, the FDA’s Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH), have jointly released a discussion paper. This document aims to engage stakeholders and explore considerations for using AI/ML in the development of drugs and biological products. The discussion is ongoing, and further information is available for those interested [Link]. The agency will seek feedback to enhance regulatory science in this area further. AI/ML is expected to play a crucial role in drug development, and the FDA aims to establish a flexible, risk-based regulatory framework that encourages innovation while ensuring patient safety.