FDA Revokes Emergency Kidney Drugs as COVID Era Fades
Published Date: 5/21/2025
Notice
Summary
The FDA has officially ended the emergency use permissions for certain kidney treatment products from Fresenius and Baxter as of January 16, 2025. This means these products can no longer be used under emergency rules, affecting hospitals and patients relying on them during COVID-19. The change helps ensure only fully approved treatments are used, with no extra costs announced.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
Emergency Use Authorizations Revoked
On January 16, 2025, the FDA revoked the Emergency Use Authorizations for Fresenius Medical Care North America’s multiFiltrate PRO System and multiBic/multiPlus solutions (EUA 048) and Baxter Healthcare Corp.’s REGIOCIT (EUA 068). This means those products can no longer be used under emergency rules and the change affects hospitals and patients who were relying on them during the COVID-19 pandemic; the notice also states the change helps ensure only fully approved treatments are used and that no extra costs were announced.
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.
2026-16959, Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.
2026-16939, GNT USA, LLC.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.
2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.
Previous / Next Documents
Previous: 2025-09063, Agency Information Collection Activities: Proposed Request and Comment Request
The Social Security Administration wants your feedback on some forms they use to collect info, especially about sharing personal records. They’re updating these forms and want to make them easier and less time-consuming for everyone. If you have thoughts, send them in by July 21, 2025, so your voice counts before changes take effect.
Next: 2025-09067, Product-Specific Guidance on Fluticasone Propionate; Draft Guidance for Industry; Availability
The FDA just released a draft guide to help drug makers test fluticasone propionate nasal sprays, making it easier to prove their products work the same as brand-name versions. This affects companies planning to submit generic drug applications and could speed up getting affordable options to market. Keep an eye out for final rules soon, which might save time and money in drug approvals!