FDA Clocks IQIRVO Review Time for Patent Perks

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.

2026-13820 — Determination That TOVALT ODT (Zolpidem Tartrate) Orally Disintegrating Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

The FDA has decided that TOVALT ODT tablets (5 mg and 10 mg) weren’t taken off the market because of safety or effectiveness problems. This means generic drug makers can now apply to sell their own versions, making it easier and cheaper for people who need this sleep aid. If approved, more affordable options could hit the shelves soon, helping patients and saving money.

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.

2026-13534 — 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!

2026-13616 — 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.

Previous: 2025-16264 — Notice of OFAC Sanctions Actions

The U.S. Treasury’s OFAC just added new people to its blacklist, meaning their money and property in the U.S. are frozen. Americans can’t do business with these folks anymore. This move helps keep bad actors out of the U.S. financial system, and it’s effective immediately.

Next: 2025-16266 — Determination of Regulatory Review Period for Purposes of Patent Extension; LUMISIGHT

The FDA has officially set the review period for LUMISIGHT, a human drug product, so its patent can be extended. This means the company behind LUMISIGHT gets more time to protect their invention and potentially make more money. Anyone involved in drug patents or development should watch this timeline closely for opportunities or changes.