Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

FDA is committed to ensuring that drugs are safe and effective while facilitating innovations in their development. As with any innovation, AI/ML creates opportunities and new and unique challenges. To meet these challenges, FDA has accelerated its efforts to create an agile regulatory ecosystem that can facilitate innovation while safeguarding public health.

As part of this effort, 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), issued an initial discussion paper to communicate with a range of stakeholders and to explore relevant considerations for the use of AI/ML in the development of drugs and biological products. The agency will continue to solicit feedback as it advances regulatory science in this area.