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FDA Draft Guidance Q&A on Food Traceability Records

The FDA has issued draft guidance in a Q&A format to help industry understand the requirements for additional traceability records for certain foods, as established by a final rule in 2022. Comments on this draft guidance are due by May 21, 2026.

FDA Guidance on Antimicrobial Drug Durations for Food Animals

The FDA's Center for Veterinary Medicine has issued guidance for sponsors of new animal drug applications concerning medically important antimicrobial drugs used in food-producing animals. The guidance aims to facilitate voluntary changes to define durations of use for these drugs to mitigate antimicrobial resistance.

Go Raw LLC Expands Cat Food Recall for Low Thiamine Levels

Go Raw LLC is expanding its voluntary recall of Quest Cat Food Chicken Recipe products due to low thiamine levels. The company is also stopping the sale of all Quest products until the issue is resolved. The expanded recall affects products distributed nationwide.

FDA Warning Letter to MedisourceRx

The FDA issued a warning letter to MedisourceRx on December 12, 2025, for failing to meet the conditions of section 503B of the FDCA. The inspection revealed that the outsourcing facility did not submit adverse event reports as required, violating federal drug laws.

FDA Warning Letter to East CK Trading Inc.

The FDA issued a warning letter to East CK Trading Inc. for significant violations of the Foreign Supplier Verification Program (FSVP) regulation. The company failed to develop and maintain an FSVP for imported foods, leading to potential refusal of admission and detention without physical examination.

FDA Warning Letter to Dynamic Stem Cell Therapy

The FDA issued a warning letter to Dynamic Stem Cell Therapy for misbranding an umbilical cord-derived stem cell product. The product is considered an unapproved new drug and an unlicensed biological product, violating the Federal Food, Drug, and Cosmetic Act. The FDA's review found claims on the company's website indicating the product is intended to diagnose, cure, mitigate, treat, or prevent disease.

FDA Warning Letter to AQ USA Inc. for Drug Manufacturing Violations

The FDA issued a warning letter to AQ USA Inc., d.b.a Ross Healthcare Inc., for significant Current Good Manufacturing Practice (CGMP) violations at its drug manufacturing facility in Lynden, Washington. The violations include inadequate laboratory testing for microbial contamination and failure to establish appropriate specifications for drug products.

FDA Warning Letter to A. Nelson & Co. Ltd

The FDA issued a warning letter to A. Nelson & Co. Ltd. for significant violations of Current Good Manufacturing Practice (CGMP) regulations, including inadequate microbial testing and unsupported expiration date extensions. The company's drug products were found to be adulterated.

Trividia Health Corrects True Metrix Blood Glucose Meters Due to Injuries and Death

The FDA issued an Early Alert regarding Trividia Health's correction of TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monitoring Systems due to reports of injuries and death. The correction updates instructions for the E-5 error code, which indicates very high blood glucose results or test strip errors.

Olympus Insufflation Units Recalled by FDA Due to Software Issues

The FDA has classified a recall of Olympus High Flow Insufflation Units (models UHI, UHI-2, UHI-3) as Class I due to a software issue that could lead to overpressure events, potentially causing serious injury or death. Olympus is removing these discontinued devices from the market, and users are instructed to immediately cease usage and quarantine affected units.

FDA Early Alert: Abiomed Heart Pump Purge Cassette Issue

The FDA issued an Early Alert regarding a potentially high-risk issue with Abiomed's Impella Purge Cassettes and Pump Sets. The issue involves an increased risk of purge leaks in Generation 1 Purge Cassettes, which could lead to pump stops and patient death. Abiomed has recalled affected products, and four serious injuries have been reported.

Boston Scientific Recalls AXIOS Stents Due to Deployment Issues

The FDA is alerting the public about a recall of Boston Scientific AXIOS Stents and Electrocautery Enhanced Delivery Systems due to issues with stent deployment. The recall has been identified as the most serious type, with 167 injuries and 3 deaths reported. Healthcare providers are instructed to immediately stop distribution or use of affected devices.

Go Raw LLC Recalls Cat Food Due to Low Thiamine

Go Raw LLC is voluntarily recalling one lot of Quest Cat Food Chicken Recipe Freeze Dried Nuggets due to low thiamine levels. The recall was initiated after one report of illness in a cat, which has since recovered. Consumers are advised to stop feeding the product and return it for a refund.

Made Fresh Salads Recalls Cream Cheese for Listeria Contamination

Made Fresh Salads, Inc. is recalling assorted flavors of cream cheese due to potential contamination with Listeria monocytogenes. The recall was initiated after the company's own sampling revealed contamination from a mixer. No illnesses have been reported to date.

Saputo USA Recalls Great Value Cottage Cheese Due to Health Risk

Saputo USA is recalling Great Value cottage cheese sold at Walmart due to potential under-pasteurization, posing a health risk. The FDA is aware of the recall, which affects products distributed in multiple states. Consumers are advised to return affected products for a refund.

Elite Treats Recalls Chicken Chips for Salmonella Contamination

Elite Treats, LLC. is recalling a single lot of chicken dog treats due to potential Salmonella contamination. The recall impacts products sold to feed stores in Alabama, Florida, Georgia, North Carolina, and South Carolina. No illnesses have been reported to date.

Lockout Supplements Recalls Chocolate Syrup for Undeclared Sildenafil

Lockout Supplements is voluntarily recalling all lots of Boner Bears Chocolate Syrup nationwide due to undeclared sildenafil. The undeclared ingredient poses a risk of dangerous blood pressure reduction when interacting with prescribed medications.

EMA Recommends Six New Medicines for Approval

The European Medicines Agency's CHMP has recommended six new medicines for marketing authorisation and nine for extension of therapeutic indications. These recommendations cover treatments for various conditions including menopausal symptoms, liver disease, a rare genetic disorder, influenza, and graft-versus-host disease.

EMA Recommends Kygevvi for Rare TK2d Disease Treatment

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Kygevvi, a new treatment for the rare genetic disease thymidine kinase 2 deficiency (TK2d). This recommendation is based on clinical study data showing improvement in motor function for pediatric patients.

EMA Recommends Withdrawal of Levamisole Medicines

The European Medicines Agency (EMA) recommends the withdrawal of marketing authorisations for medicines containing levamisole due to the serious side effect of leukoencephalopathy. This recommendation follows an EU-wide review concluding that the benefits of these medicines no longer outweigh their risks for treating parasitic worm infections.

Levamisole withdrawn from EU market due to leukoencephalopathy risk

The EMA's PRAC has recommended the withdrawal of marketing authorisations for all medicines containing levamisole from the EU market. This decision is due to the confirmed risk of leukoencephalopathy, a serious brain side effect, where the benefits of the medicine no longer outweigh the risks for treating parasitic worm infections.

CVMP Opinions and Guidelines Update

The EMA's Committee for Veterinary Medicinal Products (CVMP) adopted positive opinions for several variations to existing veterinary medicinal products and discussed pharmacovigilance signals. These updates primarily involve product information changes based on signal management processes.

MHRA Raids Illegal Weight Loss Medicine Facility

The MHRA has raided two facilities suspected of manufacturing and selling illegal weight loss medicines, seizing nearly 2,000 doses and manufacturing equipment. This action is part of an ongoing investigation into a criminal network and aims to protect the public from dangerous, unregulated products.

MHRA Alert: Fake Mounjaro (tirzepatide) KwikPens

The MHRA has issued a notice regarding fake Mounjaro (tirzepatide) 15mg KwikPens dispensed by The Private Pharmacy Clinic in Birmingham. Patients with affected pens are advised to stop use immediately and report to the MHRA. The manufacturer reported five faulty pens.

MHRA Approves Imlunestrant Tosylate for Breast Cancer

The MHRA has approved imlunestrant tosylate (Inluriyo), a new treatment for adult patients with a specific type of advanced or metastatic breast cancer. This approval provides a new therapeutic option for patients who have not responded to prior hormonal treatment.

MHRA Licenses Brensocatib for Non-Cystic Fibrosis Bronchiectasis

The MHRA has granted a marketing authorisation for brensocatib (Brinsupri), the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 years and older. This marks a significant advancement in treatment options for NCFB patients in the UK.

MHRA Class 2 Medicines Recall: KidNaps Melatonin Oral Solution

The MHRA has issued a Class 2 medicines recall for all batches of KidNaps Melatonin 1mg in 1ml Oral Solution due to out-of-specification stability results. Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are conducting the recall at the wholesaler and pharmacy level.

MHRA Statement on PATHWAYS Puberty Blocker Trial Safety

The MHRA has issued a statement regarding the PATHWAYS puberty blocker trial, expressing concerns about participant wellbeing and initiating scientific dialogue with the trial sponsor, King's College London. The agency is applying high scrutiny to ensure the safety of potential child and young person participants.

MHRA Approves Zanidatamab for HER2+ Biliary Tract Cancer

The MHRA has approved zanidatamab (Ziihera) for adult patients with HER2-positive biliary tract cancer that has progressed after previous treatment. This approval provides a new treatment option for a specific patient population with an unmet clinical need.

MHRA: UK Medical Device Testing Hits Record High, Backs AI

The UK's MHRA reported a 17% increase in approved medical device clinical investigations in 2025. The agency is implementing measures to support innovation, including a fee waiver pilot for small firms and enhanced support for AI and neurotechnology.

MHRA Medical Device Safety Notices

The MHRA has issued a list of eight medical device safety notices published between February 9-13, 2026. These notices cover various devices including ventilator circuits, tissue reconstructive material, and PET/CT scanners. The MHRA publishes these for informational purposes.

MHRA Consultation on Indefinite Recognition of CE-Marked Medical Devices

The MHRA has launched a consultation on proposals for the indefinite recognition of CE-marked medical devices in Great Britain. The consultation seeks feedback on extending current transitional arrangements and introducing an international reliance route to ensure continued supply and patient access to medical technologies. The deadline for feedback is April 10, 2026.

MHRA Consultation on CE Marked Medical Device Recognition

The MHRA has launched a consultation on proposals for the indefinite recognition of CE-marked medical devices in Great Britain. The consultation seeks views on extending transitional arrangements for MDD-compliant devices and indefinitely recognising EU MDR/IVDR compliant devices, with a comment deadline of April 10.

MHRA Seizes 20 Million Illegal ED Pills, Warns Against Online Buys

The MHRA announced the seizure of nearly 20 million illegal erectile dysfunction pills between 2021 and 2025, including 4.4 million in 2025 alone. The agency is warning the public against purchasing unauthorized medicines online due to significant health risks.

MHRA Restricts Chikungunya Vaccine IXCHIQ Use

The MHRA has introduced additional restrictions on the use of the Chikungunya vaccine IXCHIQ. The vaccine is now restricted to adults aged 18-59 without specific pre-existing health conditions, following reports of serious adverse reactions, including fatalities. Healthcare professionals must conduct a benefit-risk assessment before administration.

Pharmacy Commission Meeting Minutes and Actions

The Connecticut Commission of Pharmacy met on October 30, 2024, approving a new pharmacy application with modifications, a pharmacy remodel, and issuing fines totaling $3,000 to Walgreens for violations related to pharmacy closures and compounding standards. The commission also approved reciprocity and new applications.

Pharmacy Commission Meeting Agenda - October 30, 2024

The Connecticut Pharmacy Commission meeting agenda for October 30, 2024, outlines discussions on new pharmacy applications, remodels, pharmacy manager appointments, and reciprocity interviews. The agenda also includes requests for new non-resident pharmacy applications and updates on previously approved or denied applications.

Pharmacy Commission Meeting Minutes - Approvals and Enforcement

The Connecticut Commission of Pharmacy approved new pharmacy premises and several pharmacy remodels during its November 20, 2024 meeting. The Commission also initiated an enforcement action against Walgreens #02410 for alleged violations related to pharmacy manager changes and operating without a manager.

Pharmacy Commission Meeting Agenda

The Connecticut Pharmacy Commission met on November 20, 2024, to review 20 new pharmacy applications, including new and non-resident pharmacies, and address two legal cases. The agenda also included discussions on pharmacy remodels and reciprocity interviews.

Connecticut Commission of Pharmacy Meeting Schedule

The Connecticut Commission of Pharmacy has published its upcoming meeting dates and locations for 2024-2026. These notices provide details on regular meeting times, locations, and links to agendas and minutes for public review.

Virginia Board of Pharmacy Revised Online PIC Change Process

The Virginia Board of Pharmacy has implemented a revised, entirely online process for completing a change of pharmacist-in-charge (PIC) for pharmacy permits. This update includes electronic payment via credit card and requires uploading a one-page document to finalize the request. A revised Pharmacy Permit Application Form is also now in use for other changes.

Virginia Board of Pharmacy Staffing Concerns and Statewide Protocols Update

The Virginia Board of Pharmacy has updated its guidance on reporting pharmacy staffing concerns and has amended several statewide protocols for pharmacists. Pharmacy permit holders must review and act on staffing reports, and pharmacists can report issues directly to the board without fear of retaliation. The revised protocols cover vaccinations, tuberculosis testing, hormonal contraceptives, naloxone, influenza, and strep throat.

Virginia Pharmacy Technician Registration Requirements Updated

The Virginia Board of Pharmacy is implementing new registration requirements for pharmacy technicians, effective July 1, 2025. Individuals will need to complete an accredited training program or equivalent and pass a national certification exam to be registered.

Virginia Pharmacy Law and Regulatory Updates

The Virginia Board of Pharmacy presented updates on recent legislative and regulatory changes affecting pharmacy practice. Key changes include expanded educational standards for pharmacy technicians and new provisions for collaborative practice agreements allowing pharmacists to prescribe certain controlled substances.

Virginia Board of Pharmacy Legislative and Regulatory Updates

The Virginia Board of Pharmacy has updated its regulations regarding pharmacy technician education standards and collaborative practice agreements. Key changes include expanded options for technician training and clarified processes for pharmacists to obtain DEA registration for prescribing controlled substances.

Massachusetts: 90-day Supply for Certain Schedule II/III Prescriptions

The Massachusetts Board of Registration in Pharmacy updated its policy to allow a 90-day supply for certain Schedule II and III prescriptions, including those for opioid use disorder treatment, non-opioid stimulants, testosterone, and implantable infusion pumps. Other Schedule II and III medications remain limited to a 30-day supply.

MA Board Adopts Rapid Microbial Methods for Sterility Testing

The Massachusetts Board of Registration in Pharmacy has adopted a new policy allowing the use of Rapid Microbial Methods (RMMs) as an alternative for sterility release testing of compounded sterile preparations (CSPs). This policy outlines requirements for licensed sterile compounding pharmacies to ensure public safety when using these advanced technologies.

Rapid Microbial Methods Sterility Testing Guidance

The Massachusetts Department of Public Health has issued guidance on the use of Rapid Microbial Methods (RMMs) for sterility testing. This document outlines acceptable approaches and considerations for implementing RMMs in pharmaceutical and medical device manufacturing.

Massachusetts Pharmacy Practice Definitions

The Massachusetts Board of Registration in Pharmacy has issued a document defining key terms related to pharmacy practice. This guidance aims to clarify terminology for pharmacists and related entities operating within the state.

Pharmacy Policy: Definitions for Automated Dispensing, Compounding, and Events

The Massachusetts Board of Registration in Pharmacy has adopted Policy 2025-02, defining key terms related to automated dispensing devices, automated pharmacy systems, pharmacy processing automation, quality-related events, and serious adverse drug events. These definitions clarify regulatory expectations for pharmacies operating in the state.