FDA Crowdsources Better Pee Tests to Spot Drug-Induced Kidney Damage
Published Date: 5/13/2026
Notice
Summary
The FDA wants your help to improve tests that spot kidney damage caused by medicines. They’re asking researchers, doctors, and companies to share data by July 13, 2026, so they can make these kidney safety tests better and faster. This could lead to safer drugs and smarter health decisions without costing extra money right now.
No Economic Impacts Identified for this Document
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
Department and Agencies
Related Federal Register Documents
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.
2026-13346 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products
The FDA is updating how it collects info about Medication Guides—those important leaflets that come with some prescription drugs to keep patients safe. This affects drug makers who must follow new rules about what info to include and how to share it. Comments on these changes are open until July 31, 2026, and the update aims to keep patients informed without adding extra costs.
2026-13140 — Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
The FDA is officially putting the monitor for opioid-induced oxygen problems into a safer, easier-to-manage category called Class II. This change helps make sure the device works well and is safe, while also speeding up patient access to this important tech. The new rules took effect on June 30, 2026, and could lower costs and delays for companies making these monitors.
2026-13139 — Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
The FDA is officially classifying the skin patch that treats excessive sweating (hyperhidrosis) as a Class II device, meaning it has special safety rules but fewer hurdles than the strictest category. This change helps patients get access to this cool new treatment faster and safer, starting June 30, 2026. Companies making these patches will find it easier and less costly to bring their products to market.
2026-13006 — Determination of Regulatory Review Period for Purposes of Patent Extension; VYALEV
The FDA has officially set the review period for the drug VYALEV, which helps the company extend its patent protection. This means the patent clock can be paused, giving the drug maker more time to sell VYALEV exclusively. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by late 2026.
2026-13005 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species
The FDA is asking for public feedback on their plan to keep collecting info about new animal drugs for rare uses and less common species. This affects drug makers who want special approval and incentives for these unique animal medicines. Comments are open until July 29, 2026, and the process helps keep these important drugs safe and available without extra costs.
Previous / Next Documents
Previous: 2026-09532 — Codex Alimentarius Commission: Meeting of the Codex Alimentarius Commission
The U.S. Codex Office is hosting a virtual public meeting on June 22, 2026, to share info and gather feedback on food safety and trade rules before the big Codex Alimentarius Commission meeting in July. This affects food producers, traders, and consumers by shaping fair and safe food standards worldwide. Join in to have your say and stay ahead of changes that could impact food trade and safety.
Next: 2026-09534 — Privacy Act of 1974; System of Records
The Department of State is officially retiring and canceling the Law of the Sea Records system, known as State-19, because its files have been moved to permanent archives and are no longer kept separately. This change affects anyone involved with the Law of the Sea Advisory Committee records, but it won’t cost money or change how you interact with the government. The update is effective immediately, making the system officially closed after nearly 50 years.