FDA Approves New Sunscreen Chemical Bemotrizinol

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.

2026-15285, Product-Specific Guidances; Revised Draft Guidances for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.

2026-15303, Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy

The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the phase-changing fiducial marker for radiation therapy. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

2026-15147, Fee Rate for Using a Priority Review Voucher in Fiscal Year 2026; Correction

The FDA fixed some details about the fee for using a Priority Review Voucher in 2026. If you're submitting a drug application using one of these special vouchers, you now have to pay the fee right when you submit your application. This change affects companies working on rare pediatric diseases, tropical diseases, or medical countermeasures, and it kicks in starting February 3, 2026.

2026-15187, Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Laboratory Values." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of trial participants. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.

Previous: 2026-11575, Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Trademark Trial and Appeal Board (TTAB) Actions

The USPTO is asking for public feedback on continuing to collect info about Trademark Trial and Appeal Board (TTAB) actions, which affect businesses and individuals dealing with trademarks. This is a routine step to keep paperwork in check and won’t change fees or deadlines. You’ve got until August 10, 2026, to share your thoughts before the government gives the final thumbs-up.

Next: 2026-11579, Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to U.S. Army Corps of Engineers Miller Sands Island, Rice Island, and Cottonwood Island Pile Dike Repairs Projects on the Lower Columbia River in Oregon and Washington

The U.S. Army Corps of Engineers got permission to do pile dike repairs on Miller Sands, Rice, and Cottonwood Islands along the Lower Columbia River. This work might accidentally disturb some marine mammals, but it’s allowed because it won’t harm their populations. The projects will run for up to one year starting June 2026, helping keep the river safe and healthy without breaking any rules.