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MON 95275 Maize Nonregulated Status Determination

USDA APHIS has determined that MON 95275 maize developed by Bayer CropScience using genetic engineering is no longer a regulated article under 7 CFR part 340. The maize produces insecticidal proteins and double-stranded RNA to protect against corn rootworm. This determination, effective March 19, 2026, is based on the petition, plant pest risk assessment, and public comments received during the July-September 2025 comment period.

Routine Notice Agriculture
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Bayer Coleopteran Resistant Maize Nonregulated Status

USDA's Animal and Plant Health Inspection Service (APHIS) determined that Bayer's coleopteran-resistant maize line (event designation APHIS-2025-0021) is no longer regulated under 7 CFR Part 340. This determination means the GE maize can be freely cultivated, imported, and used in interstate commerce without further APHIS oversight. The decision applies specifically to this single maize event and does not affect other GE crop determinations.

Routine Notice Agriculture
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Response to Comments on Bayer CropScience Maize Petition

APHIS published its response to public comments submitted on Bayer CropScience's petition requesting determination of nonregulated status for genetically modified maize. The agency addressed issues raised during the comment period and explained its evaluation of the petition. This document finalizes the agency's position on the petition.

Routine Notice Agriculture
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Bayer MON 95275 maize plant pest risk assessment

USDA APHIS released a pest risk assessment for Bayer's genetically modified maize event MON 95275. The document evaluates whether the stacked trait corn poses plant pest risks under 7 CFR Part 340. The assessment is open for public comment through the regulations.gov docket.

Priority review Guidance Agriculture
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Extension of OMB Paperwork Approval Comment Period for Whistleblower Retaliation Complaint Procedures

OSHA has extended the public comment period until May 29, 2026, for its request to extend OMB approval of information collection requirements under the Regulations Containing Procedures for the Handling of Retaliation Complaints (whistleblower provisions). The agency is seeking comments on paperwork burden estimates for investigating retaliation complaints under seven environmental statutes and the Energy Reorganization Act.

Routine Consultation Employment & Labor
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UL LLC NRTL Recognition Scope Expansion

OSHA has issued a final notice expanding UL LLC's Nationally Recognized Testing Laboratory (NRTL) scope to include one additional test site at 4322 New Energy Way, Auburn Hills, Michigan 48326. The expansion becomes effective March 30, 2026. UL submitted its expansion application on October 6, 2023, and OSHA staff completed facility assessments on February 24-25, 2025.

Routine Notice Occupational Safety
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Lifecath PICC Easy Central Venous Catheter Lot Recall

ANSM issued safety alert R2608397 regarding a product recall by Vygon Germany GmbH for Lifecath PICC Easy central venous catheters. The recall affects specific lots distributed to French pharmacies and health establishments. Healthcare facilities must identify and return affected products immediately.

Urgent Enforcement Product Safety
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Sphere-9 Dual-Energy Mapping and Ablation Catheter Safety Recall

ANSM has recorded a field safety corrective action by Medtronic for the Sphere-9 dual-energy mapping and ablation catheter system (combining electroporation and radiofrequency) under reference R2608484. Healthcare establishments must review the Medtronic safety letter and take appropriate action regarding affected devices.

Urgent Enforcement Medical Devices
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TruPulse Ablation Generator Safety with Thermocool Catheter

ANSM issued safety notification R2608394 regarding a field safety corrective action by Biosense Webster Inc. for the TruPulse cardiac ablation generator (software version 2.7.0) when used with the Thermocool SmartTouch SF dual-energy catheter. Healthcare facilities using this equipment must review the manufacturer's safety communication dated March 30, 2026.

Urgent Notice Medical Devices
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SureForm 30 8mm Surgical Stapler Recall

ANSM issued safety alert R2607062 regarding Intuitive Surgical's voluntary recall of SureForm 30 8mm Gray Reload surgical stapler devices. The recall affects hospital pharmacies and surgical departments using computer-assisted surgery systems. Healthcare facilities must identify and remove affected devices from use.

Urgent Enforcement Medical Devices
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Safety alert Orbis Medication 3.x prescription software

Safety alert Orbis Medication 3.x prescription software

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Philips Respironics Trilogy Evo Ventilator Safety Alert - Nebulizer Use and Software Update

ANSM issued a safety alert (Ref. R2604745) requiring Philips Respironics Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 ventilators to receive mandatory software updates and discontinue use of non-pneumatic nebulizers. The alert addresses incorrect tidal volume delivery when non-pneumatic nebulizers are used due to faulty leak estimation, and corrects alarm delay delays and flow sensor anomalies caused by aerosol accumulation. Healthcare providers and home health service providers (PSAD) must act immediately.

Urgent Guidance Medical Devices
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BERNIER PHARMACEUTICALS Trademark Application - Cosmetics and Pharmaceutical Skin Care Products

USPTO published trademark application TM79441446 for BERNIER PHARMACEUTICALS covering cosmetics and pharmaceutical preparations including skincare products, acne treatments, and vitamin preparations. The application was filed November 24, 2025, and published March 29, 2026, initiating a standard 30-day opposition period during which third parties may challenge the registration.

Routine Notice Intellectual Property
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Clinical investigations for electrically powered devices

MHRA published guidance on clinical investigations for electrically powered medical devices. The guidance explains additional information requirements for notifying the agency of planned clinical investigations. Sponsors and clinical investigators of electrically powered medical devices should follow these requirements when submitting notifications.

Routine Guidance Healthcare
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Biological Safety Assessments for Clinical Investigations of Medical Devices

MHRA published new guidance on biological safety assessments for clinical investigations of medical devices. The guidance specifies the information MHRA expects in clinical investigation submissions to verify compliance with relevant regulations. This applies to manufacturers and sponsors conducting clinical investigations of medical devices in the UK.

Routine Guidance Medical Devices
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Clinical Investigations: Investigators' Responsibilities for Medical Devices

MHRA published guidance clarifying clinical investigators' responsibilities when conducting medical device investigations in the UK. The guidance covers submission requirements, MHRA's approval process, device labeling standards, and documentation requirements. This is informational guidance without new legal obligations.

Routine Guidance Medical Devices
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Cardinal Health EP Packs Type I Recall

Health Canada issued a Type I medical device recall for Cardinal Health Cardiac Electrophysiology (EP) Packs containing potentially affected Medline Namic Angiographic Control Syringes. The recall addresses a risk that the syringe rotating adaptor may unwind during use, causing loose connection or full disconnection between the syringe and manifold. Affected products include lots 479584 and 473022 with model number SAN30EP'XXX'.

Urgent Enforcement Medical Devices
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Clearsummit Wellness Trademark Application - Supplements

The USPTO has received an intent-to-use trademark application for 'Clearsummit Wellness' on March 28, 2026. The application covers various supplements, including mineral, homeopathic, probiotic, protein, enzyme, and nutritional supplements.

Routine Notice Food Safety
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FLOESYLA Trademark Published for Opposition

The USPTO has published the trademark application for 'FLOESYLA' for opposition. The application covers a range of pharmaceutical products, dietary supplements, and related items. The publication date for opposition is March 29, 2026.

Routine Notice Pharmaceuticals