by Admin | Mar 23, 2026 | Inspections & Compliance
FDA’s 2026 Safety and Availability Communications page for biologics says it was developed to provide the public with important information about the safety and availability of biological products. FDA’s broader “What’s New for Biologics” page also surfaces current...
by Admin | Mar 23, 2026 | Inspections & Compliance, Regulatory Updates
FDA says AEMS is its new Adverse Event Monitoring System, and the agency also maintains a dedicated page for new safety information or potential signals of serious risks identified through that system. Separately, FDA’s Drug Safety Communications page is updated with...
by Admin | Mar 22, 2026 | Inspections & Compliance
EMA says the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) was established under Regulation 2022/123 and is responsible for helping ensure a robust response to issues affecting the quality, safety, efficacy, and supply of medicinal...
by Admin | Mar 22, 2026 | Inspections & Compliance
MHRA’s variations guidance says a reduced Type II procedure, shortened from 60 days to 30 days, is available for some safety-related variations when agreed between the agency and the marketing authorisation holder. The guidance says these are generally SmPC changes...
by Admin | Mar 18, 2026 | Inspections & Compliance
MHRA’s variations guidance says a reduced Type II procedure, shortened from 60 days to 30 days, is available for variations concerning safety issues when agreed between the MHRA and the marketing authorisation holder. The guidance says these are generally SmPC changes...
by Admin | Mar 16, 2026 | Inspections & Compliance
MHRA’s December 2025 Class 4 Medicines Defect Notification for certain amitriptyline tablets says the patient information leaflet contained out-of-date safety information, including missing warnings on serotonin syndrome and dry eye. The notice also states that the...
