FDA Shares New Computer Model Tips for Human Drug Trials
Published Date: 6/24/2026
Notice
Summary
The FDA just dropped a draft guide to help drug makers pick safer starting doses for first-time human drug trials using smart computer models called QSP. This is a big deal for companies working on powerful new drugs that can cause strong reactions, like immune system activations. Comments on this draft are open until July 24, 2026, so get your thoughts in to help shape safer, smarter drug testing!
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.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-19704, Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The FDA just dropped a draft guide for companies making robot-assisted surgical devices, showing how to get their products approved before selling. If you’re in the biz, now’s the time to check it out and send your feedback by November 24, 2026. This guide aims to make the approval process clearer and smoother, potentially saving time and money down the road.
2026-19655, Jeffrey Thies: Final Debarment Order
Jeffrey Thies is banned for 10 years from importing any drugs into the U.S. because he was convicted of trafficking fake drugs. He didn’t respond to the FDA’s notice, so the ban started on September 25, 2026. He can apply to end the ban anytime, but until then, no drug imports for him!
Previous / Next Documents
Previous: 2026-12618, Product Change-Priority Mail, and USPS Ground Advantage Negotiated Service Agreements
The Postal Service is rolling out new deals for Priority Mail and USPS Ground Advantage shipping, aiming to offer special contract options for businesses. These changes, filed in June 2026, could mean better prices and tailored services for companies that ship a lot. If you’re a business that ships packages, keep an eye out for these updates—they could save you money and speed up your deliveries!
Next: 2026-12620, Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
The FDA just dropped a fresh draft guidance to help drug and biological product makers run smarter, faster clinical trials using master protocols. This update affects companies developing new medicines by clarifying how to design and submit these trials for approval. If you’re in the game, get your comments in by August 24, 2026, or risk missing out on shaping the final rules—and maybe saving time and money down the road!