FDA Guidance: Biosimilars' Bottles and Gadgets Explained

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.

2026-19074, Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices

The Food and Drug Administration (FDA) is publishing an order setting forth its final determination regarding a partial exemption from the premarket notification requirements for radiology computer- aided detection and/or diagnosis devices and computer-aided triage and notification devices that was the subject of a notice published in the Federal Register of December 29, 2025. That notice announced FDA's receipt of a petition that requested exemption from the premarket notification requirements for the following generic device types when certain conditions described in the petition were met: radiological computer-assisted diagnostic software for lesions suspicious of cancer; medical image analyzers; radiological computer aided triage and notification software; and radiological computer-assisted detection and diagnosis software. FDA denied the petition in a response issued to the petitioner on April 1, 2026. FDA is publishing this order in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

2026-18946, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

2026-18612, Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software

The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software 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 cardiovascular machine learning- based notification software. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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.

Previous: 2026-15629, NextEra Energy Duane Arnold, LLC; Duane Arnold Energy Center; Draft Environmental Assessment and Draft Finding of No Significant Impact

The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft environmental assessment (EA) and draft finding of no significant impact (FONSI) regarding the evaluation of the reasonably foreseeable environmental effects from proposed Federal actions related to reauthorizing power operations at Duane Arnold Energy Center (DAEC). Specifically, the NRC is considering issuance of an exemption and three license amendments, which were requested by NextEra Energy Duane Arnold, LLC (NEDA) to support the potential reauthorization of power operations at DAEC. The U.S. Department of Energy Office of Energy Dominance Financing is a cooperating agency on the draft EA.

Next: 2026-15631, Advisory Committee on the Medical Uses of Isotopes: Meeting Notice

The U.S. Nuclear Regulatory Commission (NRC) will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on August 17, 2026, to discuss and provide recommendations from the subcommittee on Regulatory Guide 8.39, "Release of Patients Administered Radioactive Material" review of proposed patient release revisions in the Reforming and Modernizing the NRC's Radiation Protection Framework proposed rulemaking and draft revisions to Regulatory Guide 8.39. Meeting information, including a copy of the agenda and handouts, will be available on the ACMUI's Meetings and Related Documents web page at https://www.nrc.gov/reading-rm/doc- collections/acmui/meetings/2026 or by emailing Ms. Sarah Hoenig at the contact information below.