The FDA seeks stakeholder input into AI/ML regulatory standards

Artificial intelligence (AI) has become an integral part of our daily lives. Within the pharmaceutical industry, AI and machine learning (ML) are being harnessed to aid many aspects of drug development and data analysis. In addition, the US Food and Drug Administration (FDA) has increased its focus on effectively regulating the use of these tools to ensure safety and reliability.

In combination with today’s computing power and methodological advancements, AI/ML tools carry the potential to improve the development, manufacturing, use, and evaluation of therapies, while increasing the speed of bringing treatments to market. However, the use of AI isn’t without challenges.

Concerns over ethical and security considerations - including improper data sharing, cybersecurity risks, and the amplification of data errors - must be mitigated to ensure the safe and seamless integration of AI/ML into pharma’s processes. In its efforts to advance equity in the use of AI/ML in the pharmaceutical industry, the FDA also aims to prevent algorithmic discrimination, which occurs when automated systems favour a specific category of people over others.1