ZoRaw Milk Chocolate Recalled for Undeclared Almond and Peanut
The Canadian Food Inspection Agency has issued a recall for ZoRaw brand Milk Chocolate products due to undeclared almond and peanut allergens. Consumers are advised not to consume the affected products.
Cool Fidget Toy Stress Ball Recalled for Ingestion Hazard
Health Canada has recalled the "Cool Fidget Toy Stress Ball" due to an ingestion hazard posed by small, powerful magnets. The product fails to meet safety performance criteria under the Canada Consumer Product Safety Act. Consumers are instructed to stop using and dispose of the product.
Health Canada Recall: Cream Chargers Sold for Inhalation Without Market Authorization
Health Canada has issued a recall for various brands of cream chargers sold for inhalation without market authorization. Consumers are warned not to inhale nitrous oxide products recreationally and to seek medical attention if experiencing side effects. Retailers and wholesalers are involved in the recall.
Modofo Tool 5-in-1 Detector Recalled Due to Potential Failure
Health Canada has recalled the Modofo Tool 5 in 1 Smoke and Carbon Monoxide Detector (model HTB-05) due to a potential failure to operate, posing a fire hazard. Approximately 500 units were sold in Canada between October 2025 and March 2026.
Salt of the Earth Cream Recalled Due to Chemical Hazard
Health Canada has issued a consumer product recall for Salt of the Earth Cedar and Amyris Replenish Cream due to a chemical hazard. The product contains methyl eugenol above the maximum concentration allowed by the Cosmetic Ingredient Hotlist. Consumers are advised to stop using the product immediately.
Baixiang Noodles Recalled Due to Undeclared Peanut Allergen
The Canadian Food Inspection Agency has issued a recall for Baixiang brand Artificial Spicy Beef Soup Flavor Instant Noodles due to undeclared peanut allergen. Consumers are advised not to use the affected product, and retailers are instructed to remove it from sale.
ICIM Halloumi Cheese Recalled Due to Undeclared Milk
The Canadian Food Inspection Agency has issued a recall for ICIM brand Halloumi Cheese due to undeclared sheep milk and goat milk. Consumers are advised not to use, sell, serve, or distribute the affected product.
NY Cybersecurity Regulations and Grants for Water Systems
New York Governor Kathy Hochul announced new cybersecurity regulations and $2.5 million in grants for the state's drinking water and wastewater systems. The regulations include mandatory training, incident reporting, and risk-based standards, with grants available for assessments and upgrades.
Rule, Disciplinary Action, & Remedial Plan Summaries
Rule, Disciplinary Action, & Remedial Plan Summaries
Texas Pharmacy Rules Updated
The Texas State Board of Pharmacy has updated its rules following a recent board meeting. This notice serves to inform stakeholders about the changes made to existing pharmacy regulations.
DEA Extensions, eRX Fraud Prevention, HB25 Enacted
This notice from the Texas State Board of Pharmacy (TSBP) covers several key updates. It mentions the enactment of HB25, extensions related to the DEA, and measures for e-prescribing fraud prevention. The content appears to be a summary of recent regulatory and legislative changes relevant to pharmacy practice.
Texas Pharmacy and Medical Boards Joint Statement on Communication
The Texas Medical Board and Texas State Board of Pharmacy issued a joint statement reminding physicians and pharmacists of the importance of clear communication and collaboration in patient care. The statement emphasizes professional judgment and shared responsibility in ensuring safe and legitimate prescription practices.
Professional Recovery Network, Fees and CE Updates
Professional Recovery Network, Fees and CE Updates
WHO Handbook Accelerates Hepatitis Elimination Action
The World Health Organization (WHO) has released a new implementation handbook to support countries in accelerating action towards hepatitis elimination by 2030. The handbook consolidates evidence-based recommendations and provides practical guidance for expanding prevention, testing, and treatment services.
WHO Releases New Antibiotic Profiles for Drug-Resistant Infections
The World Health Organization (WHO) has released three new Target Product Profiles (TPPs) for antibacterial agents to address critical drug-resistant infections. These profiles guide the development of new antibiotics for multidrug-resistant Gram-negative infections, Gram-positive infections in vulnerable patients, and bacterial meningitis.
Teva Octreotide Recalled Due to Manufacturing Deficiencies
Health Canada has issued a Type I drug recall for Teva Octreotide due to manufacturing site deficiencies identified at a foreign facility. These deficiencies could lead to potential quality issues, including compromised sterility and dosing accuracy. The recall is a precautionary measure.
Health Canada Health Product InfoWatch - February 2026
Health Canada's February 2026 Health Product InfoWatch includes a monthly recap of safety information, including a recall of Teva Octreotide and advisories on unauthorized products. It also announces a consultation on controlling zuranolone and new market authorizations with conditions.
Health Canada Health Product Safety Recap
Health Canada has issued its February 2026 Health Product InfoWatch, detailing recalls for Teva Octreotide due to GMP deficiencies and unauthorized health products. It also announces a consultation on controlling zuranolone under the Controlled Drugs and Substances Act.
Japan PMDA Drug Precaution Revisions for FY2025
The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has published a list of drug precaution revisions for Fiscal Year 2025, detailing updates for various nonproprietary drug names. These revisions are effective on specific dates in late 2025 and early 2026, with associated investigation summaries available.
PMDA Japan Drug Precaution Revisions
The PMDA Japan has updated drug precautions for several medications, including Andexanet alfa, Topiramate, and various VEGF/VEGFR inhibitors. These revisions reflect new safety information and investigation results, impacting the labeling and handling of these drugs.
Therapeutic Product Approvals and Indications List Update
The Health Sciences Authority (HSA) of Singapore has published updated lists of new therapeutic product approvals and new indications for registered therapeutic products, effective March 2026. These lists are intended for healthcare professionals and industry members.
HSA Charges Man for Trafficking Etomidate Vaporiser Pods
The Health Sciences Authority (HSA) of Singapore has charged a 34-year-old man for allegedly trafficking etomidate vaporiser pods. The charges follow an enforcement operation where HSA seized over 900 tablets, cough syrup, and etomidate-containing vaporiser pods. Stricter penalties for etomidate trafficking are in effect.
HSA Deepens International Partnerships for Biomedical Sector Growth
The Health Sciences Authority (HSA) of Singapore has announced deepened collaborations with Malaysia and Uzbekistan to facilitate access to medicines and medical devices. These partnerships include a formalised Medical Device Regulatory Reliance Programme with Malaysia and a Memorandum of Understanding with Uzbekistan for broader regulatory cooperation.
Raymond Chua's address at 29th Medical Device Regulators Forum
Raymond Chua's address at 29th Medical Device Regulators Forum
First Regulatory Authority Globally to Achieve WHO ML4 for Medical Devices, Expands Biomedical Role
The Health Sciences Authority (HSA) has become the first national regulatory authority globally to attain the World Health Organization (WHO) Maturity Level 4 (ML4) for medical devices regulatory systems, announced by Minister Ong Ye Kung at the IMDRF 29th Session on 10 March 2026. HSA also announced an expanded economic development role for Singapore's biomedical sector, including the co-launch of revised AI in Healthcare Guidelines (AIHGle 2.0) with MOH, and the launch of an AI-enabled Medical Device Risk Classification Tool for industry. Singapore's biopharma manufacturing output reached S$13.9 billion in 2023, while MedTech manufacturing output grew to S$18.9 billion in 2023, with approximately 100 industry-sponsored clinical trials started annually.
TGA Seizes Illegal Vapes Sold to Young People
The Therapeutic Goods Administration (TGA) in Australia, with police support, seized illegal vaping products from a store in Inverloch, Victoria, allegedly sold to minors. The TGA is investigating further regulatory action and warns retailers against targeting young people with illicit vapes.
TGA Seizes 57,000 Illegal Vaping Goods in NSW Crackdown
The Therapeutic Goods Administration (TGA) in Australia, with law enforcement support, seized over 57,000 illegal vaping products in Burwood, NSW. This action targets the illicit supply of vapes, with significant penalties including fines and imprisonment for non-compliance with the Therapeutic Goods Act 1989.
Prime Medic Group Fined for Unlawful Weight Loss Medicine Advertising
The Therapeutic Goods Administration (TGA) has issued infringement notices totaling $23,760 to Prime Medic Group and an individual for allegedly unlawfully advertising prescription-only weight loss medicines. Prime Medic Group paid the fines in January 2026.
TGA Issues Infringement Notices for Unlawful Importation and Advertising
The Therapeutic Goods Administration (TGA) has issued 11 infringement notices totaling $43,560 to 6 individuals for alleged unlawful importation of unapproved therapeutic goods and unlawful advertising of prescription-only medicines. These actions underscore the TGA's commitment to protecting public health.
TGA Releases Compliance Principles for 2026-2027 Enforcement
The Therapeutic Goods Administration (TGA) has released its compliance principles for 2026-2027, outlining a refreshed, proactive, and risk-based approach to enforcement for therapeutic goods in Australia. The principles apply across all TGA-regulated areas and will be reviewed every two years.
TGA Safety Alert: Natures Valley Collagen Builder contains undeclared sildenafil
The Therapeutic Goods Administration (TGA) has issued a safety alert regarding Natures Valley Collagen Builder tablets, which were found to contain undeclared sildenafil. Consumers are warned that the product poses a serious health risk and should not be taken.
Safety Concerns Over Imported Counterfeit Melatonin Products
The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding imported counterfeit unregistered melatonin products. Laboratory testing revealed significant discrepancies in melatonin content, with some products containing over 400% of the labelled amount and others none at all, posing serious risks to consumers, especially children.
TGA Safety Alert: Counterfeit Botox Vials Continue to be Imported
The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding the continued importation of counterfeit Botox vials into Australia. These products, packaged to appear genuine but confirmed as fake by AbbVie, pose significant public health risks and cannot be legally imported under any circumstances.
TGA Safety Alert: Ayurvedic Tablets Contain High Heavy Metals
The Therapeutic Goods Administration (TGA) has issued a safety alert regarding Kumar Kalyan Rasa tablets, an Ayurvedic medicine. Testing revealed extremely high concentrations of heavy metals, including mercury, lead, arsenic, and cadmium, posing serious health risks to consumers, particularly pregnant women and children. The TGA urges consumers to exercise extreme caution with such products.
TGA Safety Advisory: Counterfeit GLP-1 Weight Loss Products
The Therapeutic Goods Administration (TGA) has issued an updated safety advisory regarding counterfeit weight loss products falsely claiming to contain GLP-1 receptor agonists. Laboratory testing confirmed these products contain no active GLP-1 ingredients and are not included in the Australian Register of Therapeutic Goods.
Keppra (Levetiracetam) Syringe Change and Medication Error Risk
Swissmedic and UCB-Pharma AG are issuing a communication regarding a change in the application syringe for Keppra (Levetiracetam) oral solution. A new 5 ml syringe replaces the 3 ml syringe for children aged 6 months to 4 years, requiring healthcare professionals to inform caregivers about the change and proper dosing to prevent medication errors.
Voxzogo (vosoritidum) Packaging Text Error Identified
Swissmedic has identified a packaging text error on Voxzogo (vosoritidum) outer packaging. The incorrect dosage information was printed on specific batches, and affected batches have been identified. The company has issued an information letter detailing the error and corrective actions.
Yttrium Citrate (90Y)-YMM-1 Failed Sterility Test
Swissmedic has issued a communication regarding Citrate d'Yttrium (90Y)-YMM-1, Suspension for Injection, batch Z008. The batch failed its sterility test after incubation. While no immediate patient danger is expected, affected patients require close monitoring.
Cytosar (cytarabinum) Barcode Expiry Date Discrepancy Alert
Swissmedic has issued a Health Professional Communication regarding a barcode expiry date discrepancy for Cytosar (cytarabinum) 2g/20ml, batch CT32407B. The date encoded in the 2D barcode on the vial label is incorrect and does not match the legible expiry date printed on the vial.
PRAC Recommends EU Market Withdrawal of Levamisole Medicines
The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the withdrawal of marketing authorizations for medicines containing levamisole from the EU market. This decision is based on a re-evaluation of safety data, concluding that the risks associated with these drugs outweigh their benefits for treating parasitic worm infections.
ANSM Warns of Significant Risks from Off-Label Isotretinoin Use
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a warning regarding the off-label promotion and use of isotretinoin-based medications for aesthetic purposes on social media. The agency emphasizes that these drugs are strictly indicated for severe acne and carry significant risks, including psychiatric disorders and birth defects.
ANSM Ensures Continuity of Emend 125 mg Oral Suspension for Children
The ANSM has announced measures to ensure the continuity of treatment for children using Emend 125 mg oral suspension due to supply difficulties. Prescribers are advised to reserve the oral suspension for specific pediatric cases and explore alternative formulations for older children and adults. Importations are being arranged to cover demand.
ANSM Recalls Risks of Varicose Vein Sclerosing Agents
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a notice recalling the serious cardiovascular risks associated with varicose vein sclerosing agents. The agency emphasizes adherence to recommendations and provides new tutorials for reporting adverse events.
Doliprane Suspension Recall Due to Pipette Wear-Off
The French Agency for the Safety of Medicines and Health Products (ANSM) has announced a recall of 27 lots of Doliprane 2.4% oral suspension due to a manufacturing defect causing pipette graduations to wear off. This defect poses a risk of incorrect dosage and potential overdose in infants and young children.
EMA CHMP Meeting Minutes July 2025
The European Medicines Agency (EMA) has published the minutes from the Committee for Medicinal Products for Human Use (CHMP) meeting held from July 21-24, 2025. The document details discussions and opinions on various medicinal products, including initial applications and re-examinations.
EMA CHMP Meeting Agenda February 2026
The European Medicines Agency (EMA) has published the draft agenda for the Committee for Medicinal Products for Human Use (CHMP) meeting scheduled for February 23-26, 2026. The agenda outlines topics for discussion, including pre-authorisation and post-authorisation procedures for various medicinal products.
MHRA Safety Roundup February 2026: Falsified Mounjaro Pens
The MHRA has issued a safety alert regarding falsified Mounjaro KwikPen 15mg pre-filled pens found in the UK. The affected pens, batch number D873576, have faulty mechanisms and should not be supplied or used. Healthcare professionals are advised to quarantine and return affected stock.
Semaglutide Drug Linked to Optic Neuropathy Risk
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding a rare risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) associated with semaglutide (Wegovy, Ozempic, Rybelsus). Healthcare professionals are advised to refer patients with sudden vision loss for ophthalmological examination and to consider discontinuing semaglutide if NAION is confirmed.
Falsified Mounjaro KwikPen 15mg Pens Found in UK
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a notice regarding falsified Mounjaro KwikPen 15mg pre-filled pens found supplied through an online pharmacy. Batch number D873576 is affected, and the pens have a faulty mechanism, posing a safety risk to patients.
Chikungunya Vaccine (IXCHIQ) Use Restrictions Updated
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has updated restrictions for the IXCHIQ Chikungunya vaccine following a safety review. The vaccine is no longer indicated for individuals over 60 and is contraindicated for those with hypertension, cardiovascular disease, diabetes, or chronic kidney disease.
GLP-1/GIP Agonists: Strengthened Pancreatitis Warnings
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated product information for GLP-1 and dual GLP-1/GIP receptor agonists to strengthen warnings about the risk of severe acute pancreatitis, including necrotising and fatal cases. Healthcare professionals are advised to be vigilant and report suspected adverse reactions.
Isotretinoin Prescribing Guidance Updated
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated prescribing guidance for isotretinoin, removing the requirement for a second prescriber for patients under 18. New risk minimisation measures, including an updated Acknowledgement of Risk Form, have been introduced to ensure safe prescribing.
NICE Guidance: Leniolisib for PI3K delta syndrome
NICE has published highly specialised technologies guidance on the use of leniolisib (Joenja) for treating activated phosphoinositide 3-kinase delta syndrome in individuals aged 12 and over. The guidance includes evidence-based recommendations and information on commercial arrangements for NHS organisations.
NICE Guidance: Pegzilarginase for Arginase-1 Deficiency
NICE has published guidance recommending pegzilarginase (Loargys) for treating arginase-1 deficiency in individuals aged 2 years and over. The guidance includes evidence-based recommendations and details a commercial access agreement for the treatment.
NICE Guidance: Setmelanotide for Bardet-Biedl Syndrome
The UK's National Institute for Health and Care Excellence (NICE) has published highly specialised technologies guidance on setmelanotide (Imcivree) for treating obesity and hyperphagia in Bardet-Biedl syndrome. The guidance provides evidence-based recommendations for patients aged 6 years and over, with specific criteria for treatment initiation.
Cerliponase alfa for Neuronal Ceroid Lipofuscinosis Type 2 Guidance
NICE has published updated highly specialised technologies guidance (HST34) on cerliponase alfa (Brineura) for treating neuronal ceroid lipofuscinosis type 2 in children. This guidance replaces previous guidance and confirms that patients already receiving treatment can continue.
NICE Guidance: Olipudase alfa for Niemann-Pick disease types AB and B
NICE has published highly specialised technologies guidance (HST32) on the use of olipudase alfa (Xenpozyme) for treating Niemann-Pick disease types AB and B. The guidance provides evidence-based recommendations for healthcare professionals and commissioners in the UK.
NICE Guidance: Durvalumab for Muscle-Invasive Bladder Cancer
NICE has published technology appraisal guidance (TA1138) recommending durvalumab with gemcitabine and cisplatin for the neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer. The guidance includes information on commercial arrangements and reporting adverse events.
Baloxavir marboxil appraisal terminated for children
NICE has terminated the appraisal of baloxavir marboxil for treating and preventing influenza in children aged 1 to 11 years. The decision was made because the company failed to provide an evidence submission for the technology appraisal.
NICE Guidance: Epcoritamab for Follicular Lymphoma
NICE has published technology appraisal guidance (TA1139) recommending epcoritamab (Tepkinly) for treating relapsed or refractory follicular lymphoma in adults after two or more lines of systemic treatment. The guidance outlines evidence-based recommendations for healthcare professionals.
Canagliflozin Appraisal Terminated for Type 2 Diabetes in Youth
NICE has terminated the appraisal of canagliflozin (Invokana) for treating type 2 diabetes in individuals aged 10 to 17 years. The appraisal was terminated because the company failed to provide an evidence submission. NICE will review this decision if a submission is made.
NICE Guidance on Bevacizumab for Metastatic Colorectal Cancer (TA1136)
NICE has published updated technology appraisal guidance (TA1136) on the use of bevacizumab (originator and biosimilars) with fluoropyrimidine-based chemotherapy for metastatic colorectal cancer. This guidance replaces previous recommendations and provides evidence-based recommendations for healthcare professionals.
Carbachol Monograph Revision - Assay Criteria
The United States Pharmacopeia (USP) is revising the Carbachol monograph to widen the acceptance criteria for Assay from NMT 99.0%-101.0% to NMT 98.0%-102.0%. This change aims to accommodate FDA-approved products with wider specifications and is targeted for publication on May 29, 2026, with an official date of June 1, 2026.
USP Notice: Revision to Guaifenesin, Pseudoephedrine HCL, Dextromethorphan Capsules Monograph
The United States Pharmacopeia (USP) has issued a notice of intent to revise the monograph for Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules. The revision aims to update a cross-reference to an omitted monograph and incorporate the full text of a previously official assay procedure.
USP Notice: Revision to Sennosides Tablets Monograph Testing Method
The USP has issued a Notice of Intent to Revise the Sennosides Tablets monograph testing method. This revision aims to align the testing procedure with recent changes made to the general sennosides monograph, using sennosides A and B as marker compounds. The targeted official date for this revision is August 1, 2027.
Dapagliflozin Tablets Monograph Revision Notice
The USP is issuing a notice of intent to revise the Dapagliflozin Tablets monograph, with a targeted official date of June 1, 2026. This revision is being made in response to comments received, aiming to incorporate feedback into the monograph.
Adapalene Monograph Revision Proposed for Solubility Issue
The USP Small Molecules 3 Expert Committee intends to revise the Adapalene monograph to address a potential solubility issue in the Organic Impurities test. The proposed changes include allowing a larger volume of tetrahydrofuran for the standard stock solution, introducing a two-table format for retention times, and deleting the Limit of Triethylamine test.
Medicare.gov Enhanced Login Options
The Centers for Medicare & Medicaid Services (CMS) has introduced new login options for Medicare.gov, including ID.me, CLEAR, and Login.gov, to enhance user security and protect beneficiary information from fraud and identity theft. These services are free and offer various verification and support methods.
CMS Extends GENEROUS Model Application Deadline
The Centers for Medicare & Medicaid Services (CMS) has extended the application deadline for the GENEROUS Model, a drug pricing initiative for Medicaid, from March 31, 2026, to April 30, 2026. This extension provides additional time for prescription drug manufacturers to apply to participate in the model, which aims to lower drug spending and improve health outcomes.
HHS Proposed Rule for Health Insurance Exchanges 2027 Payment Parameters
HHS, through CMS, has issued a proposed rule outlining benefit and payment parameters for Health Insurance Exchanges for the 2027 plan year. The proposal includes changes to risk adjustment programs, user fees, marketing practices, and plan options, with a public comment deadline of March 13, 2026.
Crackdown on Health Care Fraud
The Trump Administration announced a major crackdown on health care fraud, including deferring $259.5 million in federal Medicaid funding to Minnesota and imposing a nationwide moratorium on Medicare enrollment for certain DMEPOS suppliers. The initiative aims to prevent fraud before it occurs and protect taxpayer dollars.
FDA Approves Filgrastim-LAHA Biosimilar
The FDA has approved FILKRI (filgrastim-LAHA), a biosimilar product, for ACCORD BIOPHARMA INC. The approval was granted on January 15, 2026, under Biologic License Application (BLA) 761027. This marks the addition of a new biosimilar option to the market.
FDA Approves Ranibizumab-leyk Biosimilar (NUFYMCO)
The FDA has approved the Biologic License Application (BLA) 761473 for NUFYMCO (ranibizumab-leyk) from FORMYCON AG. This approval marks the addition of a new biosimilar product to the market.
FDA Approves ARMLUPEG (Pegfilgrastim-unne) Biosimilar
The FDA has approved ARMLUPEG (pegfilgrastim-unne), a biosimilar drug manufactured by LUPIN LTD. This approval marks the addition of a new biosimilar product to the market, following the FDA's review process.
FDA Approval of JUBEREQ and OSVYRTI (denosumab-desu)
The FDA has approved Biologic License Application (BLA) 761424 for JUBEREQ and OSVYRTI, both containing the active ingredient denosumab-desu, submitted by ACCORD BIOPHARMA INC. This approval marks the addition of new prescription injectable medications to the market.
FDA Issues Emergency Use Authorization for F10 Antiseptic Wound Spray for New World Screwworm
The FDA has issued an Emergency Use Authorization (EUA) for F10 Antiseptic Wound Spray with Insecticide for the prevention and treatment of New World screwworm in multiple animal species, excluding domestic dogs and cats. This authorization allows for broader use than previously approved products, with specific food safety guidelines for treated animals.
FDA Guidance on Defining Drug Use Durations for Medically Important Antimicrobials
The FDA has finalized guidance (GFI #273) recommending how animal drug sponsors can voluntarily establish defined durations of use for medically important antimicrobial drugs administered in feed to food-producing animals. Over 100 drugs are affected, and sponsors are expected to submit revised labeling within approximately three years.
FDA Issues Emergency Use Authorization for Ivomec to Prevent Screwworm in Cattle
The FDA has issued an Emergency Use Authorization (EUA) for Ivomec (ivermectin) injectable solution to prevent New World screwworm infestations in cattle. This authorization allows for over-the-counter use under specific conditions and is effective until the declared emergency is terminated.
FDA Authorizes Drugs for New World Screwworm in Dogs and Cats
The FDA has issued two Emergency Use Authorizations (EUAs) for NexGard and NexGard COMBO for the treatment of New World screwworm infestations in dogs and cats, respectively. These EUAs are effective until the HHS Secretary terminates the public health emergency declaration for this pest.
FDA Approves First Generic Florfenicol and Flunixin Injection
The FDA has approved nixiFLOR, the first generic version of florfenicol and flunixin meglumine injection for treating bovine respiratory disease. This approval marks a new generic option for beef and non-lactating dairy cattle, with a withdrawal period of 38 days.
FDA Warns of Serious Risks from Unapproved Cell/Tissue Products
The FDA is warning consumers and healthcare professionals about the serious risks associated with unapproved human cell and tissue products, including patient deaths. The agency is investigating products like Laennec and reminds the public to report adverse events.
FDA Safety Labeling Change for Fluzone Vaccine
The FDA has notified Sanofi Pasteur Inc. of a required safety labeling change for Fluzone vaccine. Postmarketing studies indicate an increased risk of febrile seizures in children aged 6 months through 4 years following vaccination. This change mandates updating the 'Warnings and Precautions' section of the vaccine's labeling.
FDA Safety Labeling Change for FluMist
The FDA has notified MedImmune, LLC of a required safety labeling change for FluMist, an influenza vaccine. The change is based on postmarketing studies indicating an increased risk of febrile seizures in children aged 6 months through 4 years following vaccination.
FDA Notification: Safety Labeling Change for Influenza Vaccine
The FDA has notified GlaxoSmithKline Biologicals of a required safety labeling change for its FLUARIX influenza vaccine. Postmarketing studies indicate an increased risk of febrile seizures in children aged 6 months through 4 years following vaccination.
FDA Notification: Influenza Vaccine Safety Labeling Change
The FDA has notified ID Biomedical Corporation of Quebec (GlaxoSmithKline Biologicals) of a required safety labeling change for its FLULAVAL influenza vaccine. Postmarketing studies indicate an increased risk of febrile seizures in young children following vaccination, necessitating updates to the product's prescribing information.
FDA Lists Expiration Dates for At-Home COVID-19 Tests
The FDA has updated its list of authorized at-home COVID-19 diagnostic tests, including information on extended expiration dates. This guidance helps consumers and healthcare providers identify currently valid tests.
FDA Idea Lab for Home Health Medical Devices
The FDA has launched an Idea Lab as part of its Home as a Health Care Hub initiative to foster the development of new home health medical devices. The lab focuses on diabetes management as a test case, aiming to integrate devices for prevention, diagnosis, treatment, rehabilitation, and monitoring into patients' lifestyles.
FDA Pilot for Medical Device Recall Communication
The FDA's Center for Devices and Radiological Health (CDRH) is launching a pilot program to improve the speed of communication regarding high-risk medical device recalls. This initiative focuses initially on specific device categories and aims to reduce the time between the FDA's awareness of a potential issue and public notification.
FDA CDRH Statements on Medical Device News and Regulatory Updates
The FDA's Center for Devices and Radiological Health (CDRH) provides a collection of statements and updates on medical device news and regulatory matters. This page serves as a repository for announcements, initiatives, and reports from CDRH, offering insights into their ongoing work and priorities.
FDA Approves First Device for Pancreatic Cancer
The FDA has approved the first medical device specifically designed to treat pancreatic cancer. This approval marks a significant advancement in the treatment options available for patients diagnosed with this disease.
FDA Final Guidance on Bioresearch Monitoring Inspections
The FDA has issued final guidance detailing processes and practices for Bioresearch Monitoring inspections, as mandated by the Food and Drug Omnibus Reform Act of 2022. This guidance outlines record and information requirements, communication best practices, and inspection conduct for regulated entities.
FDA Guidance: Inclusive Cancer Trial Eligibility Criteria
The FDA has issued new guidance recommending that sponsors and institutional review boards expand eligibility criteria for cancer clinical trials to include a wider range of patients, particularly concerning performance status. This aims to improve the diversity of clinical trial populations and ensure broader applicability of cancer treatments.
FDA Guidance: Cancer Trial Eligibility Criteria
The FDA has issued new guidance regarding eligibility criteria for cancer clinical trials, specifically addressing washout periods and concomitant medications. This guidance aims to help sponsors and IRBs develop trials that are inclusive while ensuring participant safety. Comments on the guidance can be submitted at any time.
FDA Guidance: Cancer Trial Eligibility Criteria - Laboratory Values
The FDA has issued new guidance on cancer clinical trial eligibility criteria, specifically focusing on laboratory values. The guidance aims to help sponsors and institutional review boards select appropriate laboratory values to avoid unjustified exclusions of diverse patient populations.
FDA Identifies Infusion Pump Software Correction as Most Serious Recall
The FDA has identified a software correction for the Fresenius Kabi Ivenix Large Volume Pump as its most serious type of recall, indicating a potential risk of serious injury or death. Affected healthcare providers are urged to update the pump software to version 5.10.2 as soon as possible and implement temporary risk mitigation measures.
Medline Industries Recalls Electrophysiology and Ultrasound Catheters
Medline Industries is expanding a recall of reprocessed electrophysiology and ultrasound catheters due to potential residual particulates. The FDA has classified this as the most serious type of recall, as the devices could cause serious injury or death. Affected customers are instructed to return or destroy the product.
FDA Recall of Silintan Capsules for Undeclared Meloxicam
Anthony Trinh, 123Herbals LLC is voluntarily recalling all lots of Silintan capsules due to the presence of undeclared meloxicam, an approved NSAID. The FDA analysis found the product to be an unapproved new drug, posing risks of serious health events.
Modern Warrior Recalls Dietary Supplement Due to Undeclared Ingredients
Modern Warrior is voluntarily recalling its 'Modern Warrior Ready' dietary supplement due to the presence of undeclared tianeptine, 1,4-DMAA, and aniracetam. The FDA is highlighting the serious health risks associated with these ingredients, including potential life-threatening cardiovascular events and suicidal ideation.
Green Lumber Recalls Dietary Supplements for Undeclared Tadalafil
Green Lumber Holding, LLC is updating a recall for counterfeit dietary supplements falsely marketed as Green Lumber. The counterfeit products contain undeclared Tadalafil, a prescription drug, posing potential health risks. Consumers are advised to check lot numbers and discontinue use of affected products.
Gold Star Distribution Recalls FDA Products Due to Contamination
Gold Star Distribution, Inc. is recalling all FDA-regulated products held at its facility due to rodent, avian, and insect contamination and insanitary conditions. The FDA determined the facility operated under insanitary conditions, posing a significant risk of product contamination and potential illness from microorganisms like Salmonella.
Navafresh Recalls Rheumacare Capsules Due to Elevated Lead Levels
Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Rheumacare Capsules due to elevated lead levels found by the FDA. The recall impacts consumers nationwide and is being conducted with the FDA's knowledge.
Toyota SUV Recall - Faulty Second-Row Seat Recliners
Transport Canada has issued a recall for certain Toyota SUVs due to improperly manufactured second-row seat recliners that may not lock in position. Toyota recommends not using the second-row seats for passengers until repairs are completed. Owners will be notified to replace a part in the seat recliner assembly.
Katilo Classic Roomy Recalled for Salmonella Contamination
The Canadian Food Inspection Agency (CFIA) has issued a food recall warning for Katilo brand Classic Roomy due to potential Salmonella contamination. Consumers are advised not to consume, use, sell, serve, or distribute the affected product.