Biosimilar Developers Face FDA's 2026 Fee Hike

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 This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.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: 2025-14415, Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2026

Starting in fiscal year 2026, the FDA is updating the fees for groups that check food safety under the Food Safety Modernization Act. This affects accreditation and certification bodies who want to get or keep their official approval. The new fees help keep food safety checks strong and fair, with changes kicking in soon to keep everyone on track.

Next: 2025-14417, Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2026

The FDA is setting new fees for animal drug companies to pay in fiscal year 2026. If you make or sponsor animal drugs, expect some updated costs and clear payment rules starting October 1, 2025. These fees help the FDA review animal drug applications faster and keep our furry and farm friends safe and healthy.