FDA Proposes Framework to Bolster Credibility of AI Models in Drug Development

Overview

The U.S. Food and Drug Administration (FDA) has unveiled a groundbreaking draft guidance aimed at advancing the credibility of artificial intelligence (AI) models in drug and biological product development. This marks a significant milestone as it is the agency’s first formal guidance on AI in this domain, underscoring its commitment to innovation while maintaining rigorous regulatory standards.

Introduction

The integration of artificial intelligence (AI) into healthcare and drug development is revolutionizing how medical products are researched, developed, and evaluated. Recognizing the transformative potential of AI, the U.S. Food and Drug Administration (FDA) has taken a pivotal step forward by proposing its first-ever formal guidance on the use of AI in drug and biological product development. This draft guidance aims to establish a robust framework to ensure the credibility of AI models, balancing innovation with the agency’s commitment to maintaining high regulatory and scientific standards.

A Vision for Innovation with AI in Drug Development

AI has become a transformative force in drug development, enabling advancements in understanding disease progression, analyzing large datasets, and predicting patient outcomes. Since 2016, the FDA has reviewed over 500 submissions incorporating AI, reflecting its growing prominence. However, the credibility of these models—trust in their performance within specific contexts of use—remains a critical focus.

“Artificial intelligence has transformative potential to advance clinical research and accelerate medical product development to improve patient care,” noted FDA Commissioner Robert M. Califf, M.D. He emphasized the importance of balancing innovation with robust scientific safeguards to ensure safety and effectiveness.

A Risk-Based Framework for AI Credibility

The draft guidance introduces a risk-based framework for assessing and establishing the credibility of AI models. This involves defining the model’s context of use—how it addresses specific regulatory questions—and determining the activities required to validate its performance.

This framework is consistent with the FDA’s approach to reviewing drug and biological product applications that include AI components. Sponsors are encouraged to engage with the FDA early in the development process to discuss AI credibility assessments and applications.

Collaboration and Public Engagement

The draft guidance reflects input from a diverse range of stakeholders, including sponsors, manufacturers, developers, and academics.

It was informed by:

  • An FDA-sponsored expert workshop held by the Duke Margolis Institute for Health Policy in December 2022.
  • Over 800 comments from external parties on discussion papers published in May 2023.
  • The FDA’s extensive experience with AI-driven regulatory submissions.

The FDA is now seeking public feedback on the draft guidance, with a 90-day window for comments. Stakeholders are invited to weigh in on how well the guidance aligns with industry experience and whether the proposed engagement options with the FDA are sufficient.

Beyond Drugs: AI-Enabled Medical Devices

Alongside this announcement, the FDA has also published draft guidance specific to AI-enabled medical devices. Together, these efforts illustrate the agency’s holistic approach to fostering innovation across the rapidly expanding field of AI while ensuring product safety and effectiveness.

Looking Ahead: A Commitment to Ethical AI Use

As the field of AI evolves, the FDA remains dedicated to developing policies that promote responsible, ethical, and transparent AI use in medical products. Through collaborative efforts across its various centers, the agency continues to uphold its mission to protect public health while supporting cutting-edge advancements.

How to Get Involved

Stakeholders are encouraged to review the draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, and submit their feedback. This collaborative process will help shape the future of AI in drug and biological product development.

Conclusion

The FDA’s draft guidance represents a transformative step in integrating artificial intelligence into drug and biological product development. By establishing a framework that ensures the credibility of AI models, the agency is paving the way for safer, more effective, and innovative medical solutions. This initiative highlights the FDA’s dual commitment to fostering technological advancements while upholding its rigorous regulatory standards. As AI continues to reshape the landscape of healthcare, this guidance serves as a vital foundation for responsible and impactful innovation, ultimately improving patient care and outcomes.

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