Yesterday 6th January 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the Use of Artificial Intelligence in Drug and Biological Product Development.” This document provides insights and recommendations on incorporating AI technology into generating safety, efficacy, and quality data to support regulatory decisions.

The guidance emphasizes transparency in the development and application of AI models, particularly regarding their design, validation, and maintenance. It also highlights potential risks and challenges that stakeholders should address when integrating AI into drug development workflows. Early interaction between sponsors and the FDA is strongly encouraged to ensure the responsible and effective use of AI in this context.

This initiative reflects the FDA’s commitment to fostering innovation while ensuring patient safety and regulatory predictability. Industry experts and companies specializing in AI applications for healthcare have welcomed the guidance as a step toward integrating cutting-edge technologies in medical product development.

Stakeholders are invited to review the draft guidance and provide feedback to help shape a regulatory framework that supports robust, ethical, and safe AI applications in the pharmaceutical and biotechnology industries.

FDA Guidance on AI in Drug Development