FDA Bans Convicted Importer for Five Years

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.

2026-15343, Generic Drug User Fee Rates for Fiscal Year 2027

The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2027 rates for GDUFA III fees.

2026-15346, Biosimilar User Fee Rates for Fiscal Year 2027

Starting October 1, 2026, companies making biosimilar drugs will pay updated fees to the FDA for developing and getting approval for their products. These fees cover new drug development, application reviews, and yearly program costs. This helps the FDA keep biosimilar drug reviews speedy and fair while supporting innovation.

2026-15335, Medical Device User Fee Rates for Fiscal Year 2027

Starting October 1, 2026, medical device companies will see updated user fees for submitting their products to the FDA and for annual registrations. These fees help the FDA review and monitor medical devices, with special discounts available for small businesses. If you’re in the medical device world, get ready to budget for these new costs through September 30, 2027!

2026-15337, Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2027

The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies applying for direct FDA accreditation.

Previous: 2026-12164, Privacy Act of 1974; System of Records

The USPS is updating its employee training records to boost how Postal Inspection Service staff get trained and scheduled. These changes will help keep track of training, certifications, and equipment better. The updates kick in on July 17, 2026, unless people send in comments before then.

Next: 2026-12173, Commercial Driver's License: Virginia Department of Motor Vehicles; Application for Exemption

Virginia’s DMV wants permission to let commercial driver’s licenses and learner permits last longer during state emergencies. This change would help drivers keep their licenses valid without rushing to renew them in tough times. If approved, it could save time and hassle for drivers, but the public has until July 17, 2026, to share their thoughts before a final decision is made.