Arjo Tenor Mobile Lift Recall
Health Canada has issued a Type II recall for the Arjo Tenor Mobile Lift due to a brake defect that can cause uncontrolled descent. All affected units must be removed from service immediately until repaired by authorized personnel.
Monoject Syringe Recall
Health Canada has issued a Type II recall for Monoject 1mL Luer Lock Syringes due to incorrect labeling. The affected products are mislabeled as Tuberculin syringes but contain U-100 Insulin syringes. Healthcare providers are advised to contact the manufacturer for more information.
SOLTIVE Premium SuperPulsed Laser System Recall
Health Canada has issued a Type II recall for the SOLTIVE Premium SuperPulsed Laser System manufactured by Gyrus Acmi, Inc. The recall is due to a defect in the 24V power supply causing sudden power loss or failure to power on. Affected customers will be contacted by Olympus representatives to schedule service.
Health Canada Recalls Nitrous Oxide Chargers
Health Canada has issued a recall for nitrous oxide chargers sold for inhalation without market authorization. Consumers are warned not to inhale these products recreationally and to seek medical attention if side effects occur. The recall affects multiple brands sold by Total Merchandise Ltd.
Instinct Plus Endoscopic Clipping Device Recall
Health Canada has issued a Type II recall for the Instinct® Plus Endoscopic Clipping Device manufactured by Wilson-Cook Medical, Inc. due to 486 reported malfunctions where the clip fails to open. This recall is to withdraw products manufactured prior to corrective actions being implemented.
Digimerck Tablets Quality Defect: Degradation Products May Exceed Limit
The German Federal Institute for Drugs and Medical Devices (BfArM) issued a Direct Healthcare Professional Communication regarding Digimerck 0.07 mg tablets. A quality defect has been identified where degradation products may slightly exceed the specification limit by the end of the product's shelf life. Distribution was discontinued in 2022.
Melphalan AqVida: Risk of Overdose Due to Higher Concentration
The German Federal Institute for Drugs and Medical Devices (BfArM) issued a communication regarding Melphalan AqVida RTD 90 mg/ml, a new formulation with an 18-fold higher concentration than existing melphalan products. This increased concentration poses a potential risk of overdose for patients.
Tegretal Suspension Use Restricted in Newborns
The German Federal Institute for Drugs and Medical Devices (BfArM) has issued a direct healthcare professional communication restricting the use of Tegretal Suspension (carbamazepine) in newborns due to high propylene glycol content. This restriction is to prevent serious side effects in infants.
Kisqali Tablets: Updated Storage Conditions and Shelf Life
Novartis Pharma GmbH has updated the storage conditions and shelf life for Kisqali 200 mg film-coated tablets. The medicine no longer requires refrigeration and now has an authorized shelf life of 2 years. This information letter was issued by the BfArM.
Arixtra Quality Defect: Needle Discoloration and Iron Particle
The German Federal Institute for Drugs and Medical Devices (BfArM) issued a notice regarding a quality defect in Arixtra pre-filled syringes. Reports indicate brown discoloration and needle blockage due to oxidized iron particles, posing a risk to patients. Healthcare professionals are instructed not to dispense or administer affected products.
PRAC Recommendations on Safety Signals
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in February 2026. These recommendations require marketing authorisation holders (MAHs) to provide supplementary information or take regulatory action, such as updating product information.
PRAC Recommendations on Signals - January 2026 Meeting
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in January 2026. Marketing Authorisation Holders (MAHs) for affected medicinal products are required to update product information within specified timelines.
PRAC Recommendations on Safety Signals
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in November 2025. Marketing Authorisation Holders (MAHs) are required to provide supplementary information or update product information based on these recommendations, with specific deadlines for certain signals.
PRAC Recommendations on Safety Signals
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in their October 2025 meeting. These recommendations are directly actionable by marketing authorisation holders (MAHs) for updates to product information.
PRAC Recommendations on Safety Signals
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed between September 29 and October 2, 2025. These recommendations are directly actionable by marketing authorisation holders (MAHs) for both Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs).
Spinal Plug Safety Alert for Pharmacies
The French ANSM has been informed of a lot recall action for spinal plugs (Airplug T10-T12) by Groupe Lépine, registered under action number R2607057. Pharmacies are directed to consult the provided letter from the manufacturer for details.
ArjoHuntleigh Tenor Mobile Hoist Safety Alert
The French National Agency for the Safety of Medicines and Health Products (ANSM) has announced a product recall for the ArjoHuntleigh Tenor mobile hoist. This action, registered under number R2606757, is being implemented by the manufacturer ArjoHuntleigh AB.
ANSM Safety Information: Mobile Hoist and Bath Elevator
The French National Agency for Medicines and Health Products Safety (ANSM) has issued safety information regarding a mobile hoist and bath elevator from Mangar International. This notice, registered under number R2607055, alerts home healthcare providers and retailers to a safety action implemented by the manufacturer.
ANSM Safety Alert for Manosplint Cushionfoam Medical Device
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the Manosplint Cushionfoam medical device, identified by safety action number R2606620. This alert concerns a safety action initiated by the manufacturer, Kinetec SAS.
Safety alert for DermaGenius 3.0 reagent
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the DermaGenius 3.0 Complete Multiplex real-time PCR reagent. This alert, registered under number R2607183, informs medical biology analysis laboratories of a security action implemented by PathoNostics.
Health Canada Implements ICH Pharmaceutical Guidelines
Health Canada is implementing new International Council for Harmonisation (ICH) guidelines for pharmaceuticals, including M13A and Q12/Q14. These implemented ICH guidelines will take precedence over existing Health Canada guidance documents where discrepancies exist, potentially leading to amendments or withdrawals of current guidance.
ICH Consultations on Patient Preference, Extractables, and Adaptive Trials
Health Canada announced three International Council for Harmonisation (ICH) draft guidelines are open for public consultation. The consultations cover patient preference studies, extractables and leachables, and adaptive clinical trials, with comment deadlines ranging from November 2025 to April 2026.
Health Canada Implements ICH Q12 and Q14 Guidance
Health Canada has announced the implementation of International Council for Harmonisation (ICH) Q12 and Q14 guidance. The initial scope focuses on Post Approval Change Management Protocols (PACMPs) for Biologic and Radiopharmaceutical Drugs Directorate products, with further implementation details to follow.
Health Product Shortages in Canada: 2024-2025 Review
Health Canada has released its review of health product shortages for the 2024-2025 fiscal year. The report details drug and medical device shortages, including reporting requirements for manufacturers and highlights of high-impact cases. It notes a decrease in new drug shortage reports compared to the previous year.
Health Canada Proposes Reliance on Foreign Drug Authority Decisions
Health Canada is proposing a new Ministerial Reliance Order (MRO) that would allow the Minister to examine new drug submissions by relying on decisions from foreign regulatory authorities. This initiative is part of a broader Red Tape Review aimed at facilitating earlier drug availability in Canada while maintaining safety and quality standards. A 70-day consultation period is currently underway.
Insulet Recalls Omnipod 5 Pods Due to Manufacturing Issue
Insulet Corporation is initiating a voluntary medical device correction for specific lots of Omnipod 5 Pods due to a manufacturing issue that may cause insulin leaks. The FDA has been notified of this action, which impacts approximately 1.5% of global production. Customers can check lot numbers online and request replacement pods.
Lidl US Recalls Chocolate Ladybugs Due to Undeclared Hazelnut
Lidl US is recalling all lots of Favorina Chocolate Ladybugs - German-Style Nougat due to undeclared hazelnut allergen. The product was distributed to Lidl US stores in several East Coast states between January and March 2026. Consumers with hazelnut allergies are at risk of serious reactions.
HSA Seizes Over $1.1M in Vaporisers
The Health Sciences Authority (HSA) seized over $1.1 million worth of vaporisers in an operation on February 24, 2026. New penalties under the Tobacco and Vaporisers Control Act (TVCA) will take effect from May 1, 2026, targeting importers, suppliers, and premises owners.
WHO Expert Committee on Specifications for Pharmaceutical Preparations 57th Report
The WHO Expert Committee on Specifications for Pharmaceutical Preparations has released its 57th report, recommending new and revised guidance texts for pharmaceutical quality assurance. These include updated GMP for excipients, new GMP for radiopharmaceutical cold kits, revised lab quality control practices, and updated biowaiver guidelines.
WHO Expert Committee Adopts New Pharmaceutical Guidance
The WHO Expert Committee on Specifications for Pharmaceutical Preparations has adopted nine new guidance texts aimed at ensuring the quality assurance of medicines. These texts cover areas such as nitrosamine prevention, good manufacturing practices for excipients, and bioequivalence assessments, and are recommended for implementation.
WHO Expert Committee on Biological Standardization Eightieth Report
The World Health Organization has published the eightieth report of its Expert Committee on Biological Standardization. This report details the proceedings and recommendations from the committee's meeting held in October 2024, focusing on the norms and standards for biological products.
WHO Expert Committee on Pharmaceutical Preparations Meeting
The World Health Organization (WHO) announced the Sixtieth meeting of the Expert Committee on Specifications for Pharmaceutical Preparations, scheduled for October 12-16, 2026. This committee advises the Director-General on medicine quality assurance and the maintenance of The International Pharmacopoeia.
DEA Announces 10,744 Arrests in DC Safety Initiative
The Drug Enforcement Administration (DEA) announced 10,744 arrests as part of an initiative to enhance safety in Washington D.C. The operation involved collaboration between local and federal law enforcement agencies, with the goal of removing illicit substances from communities.
EMA PRAC Warns of Aseptic Meningitis Risk with Ixchiq Vaccine
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended updating the product information for the chikungunya vaccine Ixchiq to reflect recent evidence of aseptic meningitis risk, particularly in healthy young adults. This follows a safety signal investigation and is part of a regular safety assessment.
FDA Drug Shortage Update
The FDA has updated its list of current and resolved drug shortages. The notice indicates 56 drugs are currently in shortage, 45 have been resolved, and 11 have been discontinued. This update provides a snapshot of the ongoing drug supply situation.
FDA Report on Drug Shortage Prevention Efforts
The FDA has released its annual report to Congress detailing efforts in calendar year 2024 to prevent and mitigate drug shortages. The report highlights successful interventions that prevented 283 potential shortages, with only 15 new shortages identified.
FDA Extends Drug Use Dates Due to Shortages
The FDA has extended the use dates for specific lots of certain drugs to help alleviate drug shortages. This guidance allows providers and patients to use these lots beyond their labeled expiration dates, based on manufacturer stability data. The agency is not requiring relabeling but expects replacement and disposal when new product becomes available.
DEA Reports 10,712 Arrests and Reduced Drug Availability
The DEA announced 10,712 arrests and a reduction in drug availability on the streets of Washington, D.C. This enforcement action, in coordination with other law enforcement agencies, aims to improve public safety and reduce crime.
DEA Seizes $600,000 from Semi-Truck Driver
The DEA Houston Division announced the seizure of over $600,000 from a semi-truck driver suspected of transporting funds for Mexican cartels. The seizure was a joint effort with the Department of Homeland Security (DHS).
FDA Novel Drug Approvals in 2023
The FDA's Center for Drug Evaluation and Research (CDER) approved 55 novel drugs in 2023, representing new therapies not previously marketed in the U.S. The agency released a report detailing these approvals and their uses.
FDA Approves 5 New Novel Drugs in 2026
The FDA has announced the approval of five new novel drugs in 2026 for various medical conditions. These approvals include treatments for achondroplasia, hyperarginemia, schizophrenia, bipolar disorder, atopic dermatitis, and Menkes disease. The agency updated its list of novel drug therapy approvals.
FDA Novel Drug Approvals 2025
The FDA's Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025, meaning they were new and never before marketed in the U.S. The agency has released a report detailing these approvals, including drug names, active ingredients, and their approved uses.
FDA Novel Drug Approvals 2024
The FDA's Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in 2024, representing new molecular entities never before marketed in the U.S. This notice provides a list of these approvals and links to detailed reports and drug information.
FDA Novel Drug Approvals in 2022
The FDA's Center for Drug Evaluation and Research (CDER) approved 37 novel drugs in 2022, including new molecular entities (NMEs) and new therapeutic biological products (BLAs). This notice summarizes these approvals and provides a link to the full report.
NIH Removes Advanced Permission for Conference Grant Applications
The National Institutes of Health (NIH) has removed the requirement for advanced permission for conference grant applications under activity codes R13 and U13. This change aims to reduce administrative burden for applicants, with modifications to the NIH Grants Policy Statement and relevant NOFOs forthcoming.
NIH Reminder: IRB Approval Certification Required Before Award
The National Institutes of Health (NIH) issued a notice reminding the extramural research community that certification of Institutional Review Board (IRB) approval is required before award for nonexempt human subjects research. Funds cannot be used for such research without this certification, which must be the date of final IRB approval, not pending or expired.
NIH Extends Common Forms Timeline for Biographical Sketch and Other Support
The National Institutes of Health (NIH) has extended the leniency period for implementing Common Forms for Biographical Sketch and Current and Pending (Other) Support until May 2026. This notice adjusts the original January 25, 2026 deadline to allow the extramural community more time for adoption and compliance.
NIH Correction: Salary Limitation for Grants and Cooperative Agreements FY 2026
The National Institutes of Health (NIH) issued a correction to its guidance on salary limitations for grants and cooperative agreements for Fiscal Year 2026. The correction adjusts the effective date for the Executive Level II salary limitation of $228,000 from January 11, 2026, to January 1, 2026.
ICH Q1A(R2) Stability Testing Guideline Finalized
The International Council for Harmonisation (ICH) has finalized its Q1A(R2) guideline on stability testing of new drug substances and products. This revised guideline, effective February 6, 2003, provides updated recommendations for stability testing protocols across different climatic zones.
Public Consultations on Drug Development Guidelines
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is seeking public input on proposed guidelines related to drug development standards. This consultation aims to gather feedback on new and revised guidelines before their finalization.
ICH Guidelines Overview
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines across quality, safety, efficacy, and multidisciplinary areas. These guidelines aim to harmonize technical requirements for pharmaceutical registration globally.
MedPAC Recommends Medicare Physician Payment Increase
The Medicare Payment Advisory Commission (MedPAC) recommended that Congress increase Medicare physician payments by an additional 0.5 percent for 2027. The American Medical Association (AMA) welcomed the recommendation, highlighting the need for stable payments to protect patient access to care.
AMA Survey on Trust in Health Information
A recent survey highlights that Americans continue to trust physicians and medical organizations, like the AMA, for health information, despite declining confidence in federal health agencies. The AMA emphasizes its commitment to providing accurate, evidence-based guidance to patients.
Physician AI Use Doubles, Confidence Grows Amid Skill Loss Concerns
The American Medical Association's latest survey reveals that 81% of physicians now use AI in their practices, a significant increase from 38% in 2023. While confidence in AI's clinical benefits grows, concerns persist regarding potential skill loss and patient interpretation of results without physician oversight.
EDQM Publishes 22nd Edition of the Blood Guide
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the 22nd edition of its Blood Guide. This updated guide includes revisions to haemovigilance, new chapters on topical blood components and emergency planning, and updated donor selection criteria.
European Pharmacopoeia Launches All-Digital 12th Edition
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has launched the all-digital 12th Edition of the European Pharmacopoeia (Ph. Eur.). This new edition is available on a redesigned platform with a 365-day licence, marking a significant shift in how users access official quality standards for medicines in Europe.
Newsletter Transplant 2025: Organ Donation and Transplantation Data
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the 'Newsletter Transplant 2025', detailing global organ donation and transplantation activities in 2024. The report indicates a 2% increase in global transplants, with 44,021 procedures performed in Council of Europe member states.
European Donation Day 2025 Promotes Organ, Tissue, and Cell Donation
The European Directorate for the Quality of Medicines & HealthCare (EDQM) announced European Donation Day 2025, scheduled for October 11, 2025. This initiative aims to promote organ, tissue, and cell donation and honor donors, their families, and healthcare professionals. Greece will host the event, with related meetings and awareness campaigns.
PIC/S GMP Guide Revisions and Membership Updates
The EMA and PIC/S have released concept papers for public consultation on revisions to EU-PIC/S GMP Annex 6 (Manufacture of medicinal gases) and Annex 15 (Qualification and validation). These revisions aim to update guidelines to reflect current industry practices, new technologies, and ICH Q9(R1). Kazakhstan has also applied for PIC/S membership.
PIC/S EU GMP Guide Revision of Chapter 1 on Pharmaceutical Quality System
The European Commission and PIC/S are jointly consulting on a revision to Chapter 1 of the EU GMP Guide concerning Pharmaceutical Quality Systems. The update aligns with ICH Q9(R1) on Quality Risk Management and aims to enhance regulatory frameworks, ensure medicine quality, and mitigate supply chain risks.
EU-PIC/S GMP Annex 3 Revision Concept Paper Released
The EMA and PIC/S have released a concept paper proposing revisions to Annex 3 of the EU-PIC/S GMP Guide concerning the manufacture of radiopharmaceuticals. This consultation period runs until February 15, 2026, and aims to update guidance to reflect current practices and innovative approaches.
PIC/S GMP Annex Revisions and Membership Applications
The EMA and PIC/S have released concept papers for revisions to GMP Annex 15 (Qualification and validation) and Annex 6 (Manufacture of medicinal gases). These documents are open for public consultation until April 2026. Additionally, Kazakhstan has applied for PIC/S membership.
PIC/S EU GMP Guides: Consultation on Documentation, AI, and Computerised Systems
PIC/S and the European Commission have launched a joint stakeholder consultation on revisions to the EU GMP Guides, specifically Chapter 4 (Documentation) and Annex 11 (Computerised Systems), and a new Annex 22 on Artificial Intelligence. The consultation period runs from July 7, 2025, to October 7, 2025.
Field Safety Notices Issued March 2-6, 2026
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a list of Field Safety Notices (FSNs) issued between March 2 and March 6, 2026. These notices detail safety concerns and required actions for specific medical devices, including those from ArjoHuntleigh, BD, Cook, Löwenstein, and OXOID.
Class 3 Medicines Recall: Bayer Plc, Various Products
Bayer Plc is recalling specific batches of Gastrografin, Urografin 150 Solution, and Urografin 150 Injection due to an impurity exceeding acceptable limits. This recall is a precautionary measure at the pharmacy and wholesaler level.
Class 2 Medicines Recall: Curaleaf Oil
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 Medicines Recall for three batches of Curaleaf Oil due to low THC content. Healthcare professionals are instructed to stop supplying the affected batches immediately.
Ford Truck Recall - Backup Alarm May Not Sound
Transport Canada has issued a recall (2026096) for certain Ford trucks where a loose electrical connector may prevent the backup alarm from sounding. This poses a safety risk to road users. Ford will notify owners to have the connector replaced at a dealership.
Nova Bus Recall: Cooling Pump Failure Causes Power Loss
Transport Canada has issued a recall for certain Nova Bus models (2022-2025 LFS) due to a potential cooling pump failure that can lead to a loss of power. This issue poses a safety risk, increasing the potential for crashes and passenger injury.
Transport Canada Recall: Ford SUV Infotainment System Overheating
Transport Canada has issued a recall for certain Ford SUVs due to an overheating infotainment system that may affect the rearview camera display. Ford will notify owners to update the vehicle's software to address the safety risk.
Ford and Lincoln SUV Recall - Faulty EGR Valve
Transport Canada has issued a recall for certain 2025 Ford Explorer, Ranger, Bronco, Mustang, Maverick, Escape, Bronco Sport, and Lincoln Corsair and Nautilus vehicles due to a potentially faulty EGR valve. The defect could lead to a sudden loss of power, increasing the risk of a crash.
Transport Canada Recall: Ford SUV Seats
Transport Canada has issued a recall for certain Ford SUVs due to a potential issue with the driver's seat that could cause a loss of control. Ford will notify owners and provide a software update to correct the defect.
Ford Recall 2026097: Rear Driveshaft Weld Issue
Transport Canada has issued recall 2026097 for Ford vehicles due to a potential issue with the rear driveshaft weld. This defect could lead to driveshaft separation and a loss of power, increasing the risk of a crash. Ford will notify owners to inspect and replace the affected component.
Airstream RV Trailers Recalled Due to Electrical Fire Risk
Transport Canada has issued a recall for certain Airstream RV trailers due to a risk of electrical fire caused by potentially cracked wire connections in the SmartPlug 30 A shore power inlet. Owners are advised to take their trailers to a dealership for inspection and potential replacement of the power inlet.
17 Stories Furniture 14-Drawer Dressers Recalled Due to Tip-Over Hazard
The U.S. Consumer Product Safety Commission announced the recall of approximately 3,000 units of 17 Stories Furniture 14-Drawer Dressers due to tip-over and entrapment hazards. The dressers violate the mandatory standard for clothing storage units and were imported by Hong Kong Baojia International.
Stoney Games Recalls Kluster Magnet Chess Games Due to Ingestion Hazard
Stoney Games is recalling approximately 151,600 Kluster Fun Tabletop Magnet Chess Games due to a serious ingestion hazard posed by loose, high-powered magnets. The product violates the mandatory standard for toys, and consumers are advised to stop use immediately and contact the company for a replacement.
ProRider Bicycle Helmets Recalled Due to Safety Standard Violations
ProRider has recalled approximately 9,546 bicycle helmets due to violations of mandatory safety standards, posing a risk of serious injury or death. Consumers are advised to stop using the recalled helmets and seek a refund.
LFTE USA Recalls Playground Swing Set Seats Due to Fall Hazard
LFTE USA is recalling approximately 7,200 playground swing set seats due to a fall hazard caused by failing rivets. The CPSC urges consumers to stop using the recalled swings immediately and contact LFTE USA for a free replacement. One incident involving a child's minor injury has been reported.
LIVEHOM 11-Drawer Dressers Recalled Due to Tip-Over and Entrapment Hazards
The U.S. Consumer Product Safety Commission (CPSC) announced the recall of approximately 370 LIVEHOM 11-Drawer Dressers due to tip-over and entrapment hazards that pose a risk of serious injury or death to children. The dressers violate the mandatory safety standard for clothing storage units. Simplehome is offering a full refund for the recalled units.
FDA Guidance on Medical Devices for Weight Loss
The FDA has issued guidance for medical devices intended for weight loss, outlining recommendations for non-clinical testing and clinical study design to support premarket submissions. This guidance aims to promote consistency and facilitate efficient review of submissions for devices related to weight loss, reduction, management, or obesity treatment.
FDA Warning Letter to thesnuslife.com for Nicotine Pouches
The FDA issued a warning letter to thesnuslife.com for selling nicotine pouch products to individuals under 21, deeming them misbranded. The company is required to take prompt action to address violations and ensure compliance with the Federal Food, Drug, and Cosmetic Act.
FDA Warning Letter to Rio Verde Food Service Inc.
The FDA issued a warning letter to Rio Verde Food Service Inc. on February 27, 2026, citing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation following an inspection in July 2025. The company's HACCP plan for Live Oysters was found to be inadequate in controlling critical limits for temperature during receiving and storage, and its corrective action plans were insufficient.