Search

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 Correction: Salary Limitation for Grants and Cooperative Agreements FY 2026

The National Institutes of Health (NIH) issued a correction to its guidance on salary limitations for grants and cooperative agreements for Fiscal Year 2026. The correction adjusts the effective date for the Executive Level II salary limitation of $228,000 from January 11, 2026, to January 1, 2026.

ICH Q1A(R2) Stability Testing Guideline Finalized

The International Council for Harmonisation (ICH) has finalized its Q1A(R2) guideline on stability testing of new drug substances and products. This revised guideline, effective February 6, 2003, provides updated recommendations for stability testing protocols across different climatic zones.

Public Consultations on Drug Development Guidelines

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is seeking public input on proposed guidelines related to drug development standards. This consultation aims to gather feedback on new and revised guidelines before their finalization.

ICH Guidelines Overview

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines across quality, safety, efficacy, and multidisciplinary areas. These guidelines aim to harmonize technical requirements for pharmaceutical registration globally.

EDQM Publishes 22nd Edition of the Blood Guide

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the 22nd edition of its Blood Guide. This updated guide includes revisions to haemovigilance, new chapters on topical blood components and emergency planning, and updated donor selection criteria.

European Pharmacopoeia Launches All-Digital 12th Edition

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has launched the all-digital 12th Edition of the European Pharmacopoeia (Ph. Eur.). This new edition is available on a redesigned platform with a 365-day licence, marking a significant shift in how users access official quality standards for medicines in Europe.

Newsletter Transplant 2025: Organ Donation and Transplantation Data

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the 'Newsletter Transplant 2025', detailing global organ donation and transplantation activities in 2024. The report indicates a 2% increase in global transplants, with 44,021 procedures performed in Council of Europe member states.

European Donation Day 2025 Promotes Organ, Tissue, and Cell Donation

The European Directorate for the Quality of Medicines & HealthCare (EDQM) announced European Donation Day 2025, scheduled for October 11, 2025. This initiative aims to promote organ, tissue, and cell donation and honor donors, their families, and healthcare professionals. Greece will host the event, with related meetings and awareness campaigns.

PIC/S 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.

EU-PIC/S GMP Annex 3 Revision Concept Paper Released

The EMA and PIC/S have released a concept paper proposing revisions to Annex 3 of the EU-PIC/S GMP Guide concerning the manufacture of radiopharmaceuticals. This consultation period runs until February 15, 2026, and aims to update guidance to reflect current practices and innovative approaches.

PIC/S GMP 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.

Field Safety Notices Issued March 2-6, 2026

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a list of Field Safety Notices (FSNs) issued between March 2 and March 6, 2026. These notices detail safety concerns and required actions for specific medical devices, including those from ArjoHuntleigh, BD, Cook, Löwenstein, and OXOID.

Class 3 Medicines Recall: Bayer Plc, Various Products

Bayer Plc is recalling specific batches of Gastrografin, Urografin 150 Solution, and Urografin 150 Injection due to an impurity exceeding acceptable limits. This recall is a precautionary measure at the pharmacy and wholesaler level.

Class 2 Medicines Recall: Curaleaf Oil

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 Medicines Recall for three batches of Curaleaf Oil due to low THC content. Healthcare professionals are instructed to stop supplying the affected batches immediately.

Ford 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.

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.

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.

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.

FDA Guidance on Medical Devices for Weight Loss

The FDA has issued guidance for medical devices intended for weight loss, outlining recommendations for non-clinical testing and clinical study design to support premarket submissions. This guidance aims to promote consistency and facilitate efficient review of submissions for devices related to weight loss, reduction, management, or obesity treatment.

FDA Warning Letter to Rio Verde Food Service Inc.

The FDA issued a warning letter to Rio Verde Food Service Inc. on February 27, 2026, citing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation following an inspection in July 2025. The company's HACCP plan for Live Oysters was found to be inadequate in controlling critical limits for temperature during receiving and storage, and its corrective action plans were insufficient.

FDA Warning Letter to thesnuslife.com for Nicotine Pouches

The FDA issued a warning letter to thesnuslife.com for selling nicotine pouch products to individuals under 21, deeming them misbranded. The company is required to take prompt action to address violations and ensure compliance with the Federal Food, Drug, and Cosmetic Act.

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.

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.

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.

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.

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.

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.

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.

Primal Herbs Recalls Volume Due to Undeclared Sildenafil

Primal Supplements Group LLC is voluntarily recalling all orders of Primal Herbs Volume due to the undeclared presence of sildenafil, an active ingredient in Viagra. The FDA confirmed the undeclared ingredient, which poses a risk of dangerous blood pressure drops when interacting with nitrates.

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.

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.

Rule, Disciplinary Action, & Remedial Plan Summaries

Rule, Disciplinary Action, & Remedial Plan Summaries

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.

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.

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.

HSA Achieves WHO ML4 Recognition for Medical Devices, Expands Biomedical Role

The Health Sciences Authority (HSA) in Singapore has achieved the highest World Health Organization (WHO) Maturity Level (ML4) for medical devices regulatory systems, becoming the first national authority globally to do so. HSA is also expanding its economic role to support the biomedical sector's growth.

Raymond Chua's address at 29th Medical Device Regulators Forum

Raymond Chua's address at 29th Medical Device Regulators Forum

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.