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Artificial Intelligence: US FDA Outlines 7 Steps To Establishing Model Credibility

 
• By Sue Sutter

The risk-based framework described in a new draft guidance starts with defining the question of interest and context of use and includes development and execution of a credibility assessment plan. The guidance is limited to AI models used to support regulatory decisions about drug safety, effectiveness or quality.

Artificial intelligence
The FDA outlined a seven-step framework for establishing credibility of artificial intelligence models. (Shutterstock)
Key Takeaways
  • A new FDA draft guidance describes a seven-step, risk-based framework for assessing and demonstrating the credibility of artificial intelligence models when outputs are used to make drug regulatory decisions.

The US Food and Drug Administration wants drug sponsors to follow a seven-step framework for assessing and establishing the credibility...

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