Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Comment Request
Published Date: 1/7/2025
Notice
Summary
The FDA is rolling out a draft guide to help drug and biological product makers use artificial intelligence (AI) safely and smartly when making decisions about their products. This affects companies working on medicines and biologics, aiming to boost safety and quality without slowing things down. Comments on this guide are open until April 7, 2025, so industry folks have time to weigh in before the final rules drop.
Analyzed Economic Effects
5 provisions identified: 4 benefits, 1 costs, 0 mixed.
Risk-based AI credibility framework
The FDA proposes a risk-based credibility assessment framework that sponsors should use to establish and document the credibility of AI models for a specific context of use (COU). The framework asks sponsors to plan, gather, organize, and document credibility evidence and to tailor oversight, performance acceptance criteria, and risk mitigation to the model risk and COU.
Guidance applies across product lifecycle
The draft guidance covers AI models used to produce information or data that support regulatory decision-making in the nonclinical, clinical, postmarketing, and manufacturing phases of the drug and biological product life cycle. If your AI use produces data or information for safety, effectiveness, or quality decisions in those phases, it falls within this guidance's scope.
Certain AI uses excluded from scope
The guidance does not apply to AI used in drug discovery or to AI used solely for operational efficiencies (for example internal workflows or drafting submissions) when those uses do not impact patient safety, drug quality, or study result reliability. Sponsors with those AI uses are not covered by this draft guidance for regulatory decision-making purposes.
Options for early FDA engagement
The draft guidance describes options for sponsors to engage with FDA early to set expectations about appropriate credibility assessment activities based on model risk and COU and to identify challenges. It also notes sponsors may choose to complete the guidance's steps without early engagement and keep postmarketing documentation in standard operating procedures for agency review upon request.
Comment deadline and feedback priorities
FDA is accepting public comments on this draft guidance and the proposed collection of information through April 7, 2025. FDA specifically requests feedback on how well the proposed risk-based credibility framework aligns with industry experience and whether additional guidance on AI in postmarketing pharmacovigilance would be helpful.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Related Federal Register Documents
2026-11331 — Hand Trucks and Certain Parts Thereof From the People's Republic of China: Final Results of the Expedited Fourth Sunset Review of the Antidumping Duty Order
The U.S. Department of Commerce decided to keep the antidumping duties on hand trucks and parts from China because dropping them could lead to unfair low prices again. This means importers from China will still pay extra fees to keep things fair for U.S. businesses. These rules stay in effect starting June 5, 2026, protecting American companies from cheap imports that could hurt them.
2026-11280 — Self-Regulatory Organizations; NYSE American LLC; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change To Amend Sections 1003 and 1009 of the NYSE American Company Guide
The NYSE American Exchange wants to change its rules to require companies to keep a certain market value to stay listed. This affects companies listed on the exchange and could lead to some being removed if they don’t meet the new standards. The SEC is reviewing this change and will decide by June 18, 2026, so companies and investors should watch for updates that might impact stock listings and market activity.
2026-11296 — Notice of Determinations and Request for Comments Concerning Actions in Section 301 Investigations of Acts, Policies, and Practices of Various Economies Related to the Failure To Impose and Effectively Enforce a Prohibition on the Importation of Goods Produced With Forced Labor
The U.S. Trade Representative found that many countries aren’t stopping goods made with forced labor from entering the U.S. To fix this, they’re planning to add extra taxes (tariffs) on products from these countries, with rates between 10% and 12.5%. They’re also offering a special deal for some clothing imports and want your thoughts before finalizing these changes by early July 2026.
2026-11327 — Proposed Revisions to the National Handbook of Conservation Practices
The USDA’s Natural Resources Conservation Service is updating some rules in the National Handbook of Conservation Practices to help farmers and landowners protect the environment better. These changes could affect how conservation projects are planned and done, and the public can share their thoughts until July 6, 2026. No big costs are expected, but the updates aim to make conservation easier and more effective.
2026-11276 — Long Island Rail Road's Request To Amend Its Positive Train Control System
The Long Island Rail Road wants to make some changes to its safety system that helps prevent train crashes, called Positive Train Control (PTC). They asked the government for approval on May 21, 2026, and now the public can share their thoughts until June 25, 2026. These updates aim to keep trains safer without causing delays or extra costs for riders.
2026-11282 — Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Amend It Rules Related to Binary Options
The Cboe Exchange wants to update its rules to let traders buy and sell binary options on more indexes, with flexible settlement times and new position limits. The SEC is taking extra time, until July 19, 2026, to review these changes carefully. This affects traders and could impact how they manage risk and trade binary options on the Exchange.
Previous / Next Documents
Previous: 2024-31541 — Validation and Verification of Analytical Testing Methods Used for Tobacco Products; Guidance for Industry; Availability
The FDA just released final guidance to help tobacco companies make sure their testing methods for ingredients and product stability are accurate and reliable. This means better, more consistent data when companies submit info about their tobacco products. If you’re in the tobacco biz, get ready to follow these updated testing rules starting now—no extra fees, just clearer standards!
Next: 2024-31543 — Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The FDA just dropped a draft guide to help companies make and sell medical devices with AI software. It explains what info to include so the FDA can check these devices are safe and work well, plus tips on managing them from start to finish. If you’re in the AI medical device game, get ready to share your thoughts by April 7, 2025, before the rules get final—and yes, this could affect your product plans and budgets.