On 6 Jan 2024, the FDA released a new draft guidance. 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.
This guidance provides recommendations to industry on the use of AI to produce information or data intended to support regulatory decision-making regarding safety, effectiveness, or quality for drugs. Other uses of AI by industry are not covered.
The draft guidance provides what the FDA calls ‘7 steps to AI credibility’. These are:
The draft guidance also discusses maintenance, or management of model changes to ensure it remains fit for use over the drug product’s life cycle.
The document together the link for submitting comments can be found here
