FDA Issues Model-Based Drug Development Guidelines
Published Date: 6/3/2026
Notice
Summary
The FDA just released new guidance to help drug makers use smart computer models to develop medicines faster and safer. This update sets clear rules on how to plan, check, and share model-based evidence, making drug development smoother for companies worldwide. Starting now, drug developers should follow these guidelines to save time and money while working with regulators.
No Economic Impacts Identified for this Document
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-18432, Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the temperature regulation device for esophageal protection during cardiac ablation procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2026-18426, Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
The Food and Drug Administration (FDA) is classifying the whole room microbial reduction device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the whole room microbial reduction device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2026-18433, Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
The FDA is officially classifying a new device that protects the esophagus during heart procedures as a Class II device, meaning it’s safe and effective with some special rules. This change helps patients get access to this cool innovation faster by cutting down on red tape. The new classification took effect on September 10, 2026, but has been in place since September 6, 2023, making it easier and potentially cheaper for makers to bring this device to market.
Previous / Next Documents
Previous: 2026-11111, Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on National Security and Emergency Preparedness Communications (NSEPC)
The Cybersecurity and Infrastructure Security Agency (CISA) is asking for public feedback on how they collect opinions about national security and emergency messages. This helps make sure their communications are clear and useful without causing extra hassle. Comments are open until July 6, 2026, and no costs or big changes are expected.
Next: 2026-11113, Tuna Tariff-Rate Quota for Calendar Year 2026 for Tuna Classifiable Under Subheading 1604.14.22, Harmonized Tariff Schedule of the United States (HTSUS)
In 2026, the U.S. will allow up to 16.36 million kilograms of tuna in airtight containers to enter with a lower 6% tariff. If imports go over that amount, a higher 12.5% tariff kicks in. This affects tuna importers who need to watch their shipments from January 1 to December 31, 2026, to avoid extra costs.