💊FDA Decision on MOBIC Allows Continued Generic Approvals
The Food and Drug Administration (FDA or Agency) has determined that MOBIC (meloxicam) tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Learn More🚛CDL Exemption Notice for International Motors by FMCSA
FMCSA announces its final decision to renew the exemption granted to International Motors, LLC (International), formerly known as Navistar, Inc.,\1\ from the commercial driver's license (CDL) regulations for one of its commercial motor vehicle (CMV) drivers. The exemption allows Mr. Thomas Nickels, Senior Vice President of the Cabin and Chassis R&D Group for International's parent company, TRATON SE, to test drive various International test fleet vehicles on roads of the United States. ---------------------------------------------------------------------------
Learn More🍼FDA Guidance on Lead Levels in Food for Babies and Young Children
The Food and Drug Administration (FDA) is correcting a notice of availability that appeared in the Federal Register on January 7, 2025. The document announced the availability of a final guidance for industry entitled "Action Levels for Lead in Processed Food Intended for Babies and Young Children." The notice published with an error in the Background section. This document corrects the error.
Learn More⚛️NRC Notice on Duke Energy's License Renewal for Robinson Plant
The U.S. Nuclear Regulatory Commission (NRC) has received an application for the renewal of Facility Operating License No. DPR-23, which authorizes Duke Energy Progress, LLC (Duke, the applicant) to operate H.B. Robinson Steam Electric Plant (Robinson), Unit 2. The renewed license would authorize the applicant to operate Robinson, Unit 2, for an additional 20 years beyond the period specified in the current license. The current operating license for Robinson, Unit 2, expires July 31, 2030.
Learn More📜Bytecode Alliance Foundation Membership Changes - Antitrust Notice
The Department of Justice provides notice regarding the Bytecode Alliance Foundation, detailing changes in its membership as mandated under the National Cooperative Research and Production Act. Companies like Red Hat, Broadcom, and Cisco have withdrawn from the collective, while the foundation plans to continue filing notifications for any further membership changes.
Learn More🦅Regulatory Update
On October 4, 2021, the U.S. Fish and Wildlife Service (Service) published an advance notice of proposed rulemaking in the Federal Register. The Service is withdrawing this advance notice of proposed rulemaking, consistent with an order by the Secretary of the Interior.
Learn More🏛️Membership Changes in 1EdTech Consortium
The Department of Justice has published a notice regarding membership changes in the 1EdTech Consortium, Inc. This notice informs stakeholders about new additions and withdrawals in the consortium and emphasizes ongoing compliance with the National Cooperative Research and Production Act, particularly concerning antitrust regulations.
Learn More💊FDA Approves TREMFYA Under Rare Pediatric Disease Voucher
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application (Supplement-24) for TREMFYA (guselkumab), approved March 20, 2025, meets the criteria for redeeming a priority review voucher.
Learn More🏥Medicare's Public Meeting on New Clinical Lab Test Codes for 2026
This notice announces a public meeting to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule for calendar year 2026. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.
Learn More💰Proposed Rule Change for Bitcoin Trust Options Trading
The Securities and Exchange Commission is reviewing a proposed rule change by MIAX Sapphire, LLC to list and trade options on the VanEck Bitcoin Trust. The Trust aims to provide investors with a cost-efficient means of gaining exposure to Bitcoin while adhering to current exchange rules governing ETF options. This filing is intended to enhance market transparency and improve investor access to Bitcoin-related investments.
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