FDA Draft Guidance on Use of AI to Support Regulatory Decision-Making for Drug and Biological Products
- Date
- January 20, 2025
- Category
US Regulations
- Description
On the 6th of January FDA released new draft guidance titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products”. Comments on the draft are due by 7 April 2025. This draft takes into consideration the more than 800 comments that FDA received in response to their two discussion papers that were published in 2023.
The draft guidance only applies to AI models that produce information or data to support regulatory decision-making regarding drug and biologic safety, effectiveness or quality. Other uses of AI by industry are not covered.
The draft guidance provides what the FDA calls ‘7 steps to AI credibility’. These are:
- Define the question of interest that will be addressed by the AI model,
- Define the context of use (COU) for the model,
- Assess the model risk,
- Develop a plan to establish the credibility of model output within the COU,
- Execute the plan,
- Document the results of the credibility assessment plan and discuss deviations from the plan,
- Determine the adequacy of the AI model for the COU,
The draft guidance also discusses maintenance, or management of model changes to ensure it remains fit for use over the drug product’s life cycle.
This draft guidance can be found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological