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.
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.
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.
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.
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.
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.
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.
NY Health Urges Colorectal Cancer Screening for Adults Under 50
The New York State Department of Health is urging adults aged 45 and older to undergo colorectal cancer screening, as it is now a leading cause of cancer death for those under 50. The department highlights that screening can prevent or detect the cancer early, and aims to improve current screening rates.
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 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).
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 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 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.
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 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.
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.
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.
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.
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.
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.
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 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.
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.
SAMHSA Proposed Collection for Underage Drinking Prevention Activities
The Substance Abuse and Mental Health Services Administration (SAMHSA) has published a notice requesting public comment on a proposed collection of information related to underage drinking prevention activities. This notice initiates a 60-day comment period for interested parties.
SAMHSA Extends NSDUH Field Tests; Comment Deadline May 12
The Substance Abuse and Mental Health Services Administration (SAMHSA) has extended the field tests for the National Survey on Drug Use and Health (NSDUH). The agency is requesting public comments on this extension, with a deadline of May 12, 2026.
HHS-Certified Laboratories for Urine/Oral Fluid Drug Testing
The Substance Abuse and Mental Health Services Administration (SAMHSA) has published the current list of HHS-certified laboratories and instrumented initial testing facilities for urine and oral fluid drug testing. This notice serves as an informational update for federal agencies and relevant parties.
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.
Colorado Identifies Additional Measles Cases
Colorado public health officials announced two additional measles cases in Broomfield County, with a third under investigation. The notice identifies a potential public exposure location and advises individuals to seek vaccination or medical consultation if exposed.
Colorado MMR Vaccine Reminder Program
The Colorado Department of Public Health and Environment is sending reminders to approximately 200,000 children who may be overdue for their MMR vaccine. This outreach is part of a routine public health program and occurs during a national surge in measles cases.
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.
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 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 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.
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 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).
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.
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 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 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.
AHRQ Social Media Presence Update
The Agency for Healthcare Research and Quality (AHRQ) has updated its social media presence, providing links to its official accounts on platforms including Instagram, Facebook, LinkedIn, and YouTube. This notice informs the public about where to find AHRQ research, tools, and training information online.
AHRQ Impact Case Studies Highlight Evidence-Based Tools
The Agency for Healthcare Research and Quality (AHRQ) has published new impact case studies highlighting the use of its evidence-based tools and publications. These studies showcase how various healthcare organizations and policymakers have successfully implemented AHRQ resources to improve healthcare quality and safety.
AHRQ Stats: Healthcare Quality Statistics on Adverse Events, Maternal Deaths, Opioid Use
The Agency for Healthcare Research and Quality (AHRQ) has released updated statistics on healthcare quality. The data highlights adverse drug events involving hypoglycemic agents, disparities in healthcare expenditures by race/ethnicity, and maternal death rates by income and race/ethnicity.
AHRQ Press Releases on Patient Safety, Quality, and Research
The Agency for Healthcare Research and Quality (AHRQ) publishes press releases regarding patient safety, quality, and research. Recent releases cover topics such as a new dashboard for tracking patient harm reduction, reports on sepsis burden, and funding opportunities for state-based health improvement solutions.
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 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 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.
HRSA Health Centers Served Record 32.4 Million Patients in 2024
The Health Resources and Services Administration (HRSA) announced that HRSA-funded health centers served a record 32.4 million patients in 2024. The data highlights quality improvements and recognizes nearly 1,000 health centers with Community Health Quality Recognition badges.
HRSA 340B Rebate Model Pilot Program Application and Comment Period
The Health Resources and Services Administration (HRSA) has announced a voluntary 340B Rebate Model Pilot Program for 2026 drugs. HRSA is seeking public comment on the application process for manufacturers and the pilot program itself, with a 30-day comment period.
HRSA Lowers Out-of-Pocket Medication Costs at Health Centers
The Health Resources and Services Administration (HRSA) has issued updated award terms requiring HRSA-funded health centers to provide insulin and injectable epinephrine to low-income patients at or below the price paid by the center through the 340B Drug Pricing Program. This action aims to lower out-of-pocket costs for life-saving medications nationwide.
Deer Oaks HIPAA Resolution Agreement and Corrective Action Plan
The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has entered into a Resolution Agreement and Corrective Action Plan with Deer Oaks, a covered entity under HIPAA. The agreement resolves allegations of impermissible disclosure of protected health information (PHI) and a subsequent data breach, requiring Deer Oaks to pay a resolution amount and implement corrective actions.
Comstar, LLC HIPAA Resolution Agreement and Corrective Action Plan
The US Department of Health and Human Services (HHS) has entered into a resolution agreement with Comstar, LLC, a business associate under HIPAA. Comstar will pay $75,000 and comply with a corrective action plan to resolve alleged violations of HIPAA's Privacy, Security, and Breach Notification Rules following a ransomware attack affecting 585,621 individuals.
HHS - Syracuse ASC Pays $250,000 for HIPAA Violations
The U.S. Department of Health and Human Services (HHS) has reached a resolution agreement with Syracuse ASC, L.L.C. for violations of HIPAA Rules. Syracuse ASC will pay $250,000 and comply with a Corrective Action Plan to address failures in risk analysis and timely breach notifications.
HHS Settles HIPAA Breach Case with BST CPAs for $175,000
The U.S. Department of Health and Human Services (HHS) has settled a HIPAA breach case with BST & Co. CPAs, LLP for $175,000. The settlement resolves allegations that BST failed to conduct a risk analysis following a ransomware attack that impacted the protected health information of 170,000 individuals.
MMG Fusion Settles HIPAA Violations for $10,000
The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has reached a resolution agreement with MMG Fusion, LLC, a business associate handling protected health information (PHI). MMG Fusion will pay $10,000 to settle alleged violations of HIPAA's Privacy, Security, and Breach Notification Rules following a data breach that exposed patient information.
Arizona Medicaid SPA AZ-25-0029 Updates Nursing Facility Rates
The Centers for Medicare & Medicaid Services (CMS) approved Arizona State Plan Amendment AZ-25-0029, updating fee-for-service payment rates for nursing facility services. These updated rates are effective January 1, 2026.
Minnesota Medicaid SPA 25-0036: MAT Services Recovery Peers
The Centers for Medicare & Medicaid Services (CMS) approved Minnesota's State Plan Amendment (SPA) 25-0036, effective October 1, 2025. This amendment removes the end date for Medication Assisted Treatment (MAT) services and adds recovery peers and treatment coordinators as qualified providers.
North Dakota Medicaid State Plan Amendment Approval
The Centers for Medicare & Medicaid Services (CMS) approved North Dakota's State Plan Amendment (SPA) 26-0008 on March 10, 2026. This amendment updates the designee responsible for State Plan submissions. The SPA was effective January 5, 2026.
South Dakota Medicaid SUD/IMD Template and Provider List Updates
The Centers for Medicare & Medicaid Services (CMS) approved South Dakota's Medicaid State Plan Amendment (SPA) 25-0015. This amendment updates the Substance Use Disorders/Institutions for Mental Diseases template and revises the provider list for school-based direct services and administrative claiming.
Medicare Transmittals: Policy Changes and Coverage Updates
The Centers for Medicare & Medicaid Services (CMS) has issued several transmittals in late 2024 detailing policy changes and coverage updates for Medicare. These updates affect various aspects of Medicare benefits, billing, and claims processing, with implementation dates extending into 2025.
Medicare Policy Updates and Coding Changes
The Centers for Medicare & Medicaid Services (CMS) has issued several transmittals detailing policy updates and coding changes for Medicare in 2026. These updates cover various areas including the Review Choice Demonstration, SSI/Medicare beneficiary data, preventive services, error rate testing, and specific payment systems. The implementation dates for these changes range from April to May 2026.
2025 Medicare Transmittals and Implementation Dates
The Centers for Medicare & Medicaid Services (CMS) has released its 2025 transmittals, detailing updates and implementation dates for various Medicare programs. These documents outline changes to payment systems, data reporting, and operational procedures for healthcare providers.
Medicare Transmittals and Updates
The Centers for Medicare & Medicaid Services (CMS) has issued several transmittals and updates for Medicare in late December 2023. These documents provide guidance on coding, payment systems, and policy clarifications for healthcare providers. Key updates include changes to ICD-10, IVIG items, ACO REACH model APIs, and the ASC payment system.
Medicaid Applied Behavior Analysis Audits for Children with Autism
The HHS Office of Inspector General announced a series of audits of Medicaid Applied Behavior Analysis (ABA) services for children with autism. These audits aim to determine if state Medicaid agencies' payments complied with federal and state requirements, following identification of questionable billing patterns.
Medicare Advantage Risk-Adjustment Data - Documentation Review
The HHS OIG announced a series of projects to review documentation supporting diagnosis codes submitted by Medicare Advantage organizations to CMS. CMS estimates 9.5% of payments to MA organizations are improper due to unsupported diagnoses.
Kidney Transplant Patient Selection Criteria and Waitlist Outcomes Report
The HHS Office of Inspector General has completed a report on patient selection criteria for kidney transplants and waitlist outcomes. The report found that half of patients evaluated for a kidney transplant in 2023 were not added to the waitlist, with psychosocial criteria being a common reason for denial.
Hospital Billing Requirements Review for Overpayment Risk
The Centers for Medicare and Medicaid Services (CMS) announced a review series focused on hospital billing requirements to identify overpayment risks. A completed project for Sarasota Memorial Hospital identified at least $12.1 million in Medicare overpayments due to non-compliance with billing requirements.
HHS Agencies' Drug Control Funds Review Completed
The HHS Office of Inspector General has completed its mandatory review of HHS agencies' annual accounting of National Drug Control Program funds for fiscal year 2025. The review, which assessed compliance with ONDCP circular requirements, found no material modifications needed for the CDC and FDA reports.
Joint Commission Launches Accreditation 360 for Healthcare Accreditation
The Joint Commission has launched Accreditation 360, a new approach to healthcare accreditation and certification. This initiative aims to simplify processes, reduce burden by removing over 700 requirements, and enhance patient safety through outcome-based measures and data analytics.
NAHQ, Joint Commission Launch Accreditation Micro-Credential
The National Association for Healthcare Quality (NAHQ) and Joint Commission have launched a new Regulatory & Accreditation (R&A) Micro-Credential. This program aims to equip healthcare quality professionals with practical skills for survey readiness and adherence to regulatory requirements.
Joint Commission Launches Children's Health Strategy and Revises Standards
The Joint Commission has launched a new children's health strategy and is revising its accreditation and certification standards to better address the unique needs of pediatric patients. This initiative involves forming a Children's Healthcare Advisory Committee to guide the revisions.
Joint Commission, STS, ACC Partner for New Cardiac Certification
The Joint Commission has partnered with The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) to launch a new cardiac care certification. This certification will leverage existing clinical data from STS and ACC patient registries, aiming to reduce the burden on healthcare organizations while focusing on patient outcomes.
Joint Commission and NQF Align Sentinel Event Lists
The Joint Commission and the National Quality Forum (NQF) have aligned their lists of serious reportable events, also known as sentinel events. This alignment aims to standardize reporting and improve patient safety initiatives within healthcare organizations accredited by The Joint Commission.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.