FDA Spells Out Biosimilar Supplement Filing Rules

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.

2026-13778 — Medical Device User Fee Amendments; Public Meeting; Request for Comments

The FDA is planning a public meeting on August 5, 2026, to talk about renewing fees that medical device makers pay to help speed up device reviews from 2028 to 2032. This affects companies making medical devices and could impact how much they pay and how fast their products get approved. The current fee program ends in September 2027, so the FDA wants your thoughts before finalizing new rules and fees.

2026-13716 — New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor

The FDA just updated the rules for new animal drugs, approving several new and generic medicines for pets and farm animals from early 2026. These changes help keep animal treatments safe and effective, and the updates take effect right away on July 7, 2026. If you’re a drug maker or animal caretaker, these approvals and sponsor changes could impact what medicines are available and when.

2026-13616 — Endo Operations Limited, et al.; Withdrawal of Approval of 34 New Drug Applications

The FDA is officially pulling the plug on 34 drug approvals because the companies stopped selling these medicines. This change kicks in on August 5, 2026, and it mainly affects drug makers like Endo Operations and Pfizer. No money penalties here—just a clean break, but companies can ask to reapply if they want to bring the drugs back.

2026-13534 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Hearings

The FDA is asking for public feedback on how it collects information for formal hearings and administrative rules. This affects businesses and people who interact with the FDA, with no new costs but a chance to improve paperwork processes. Comments are due by August 5, 2026, so don’t miss your chance to weigh in!

2026-13519 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices

The FDA is asking for public feedback on their paperwork rules for approving the most important and risky medical devices, like life-support machines. This review helps keep devices safe and effective before they hit the market. If you have thoughts, you’ve got until August 5, 2026, to share them—no cost changes, just a check-in on the info they collect.

Previous: 2025-17289 — Foreign Endangered Species; Receipt of Permit Applications

The U.S. Fish and Wildlife Service is asking the public to share their thoughts on requests to work with endangered animals from other countries. These activities usually need special permission to make sure the animals stay safe. If you care about protecting these rare species, now’s the time to speak up before permits are approved!

Next: 2025-17291 — Sugar From Mexico; Determinations

The U.S. International Trade Commission decided to keep protections on sugar imported from Mexico because stopping them could hurt American sugar producers. This means tariffs or limits on Mexican sugar will stay in place to protect U.S. jobs and businesses. The decision was finalized in early September 2025 and affects sugar importers and U.S. sugar farmers alike.