UK – Updated NICE guidance recommends more targeting of antibiotics to those at the...
NICE has today (Wednesday, 31 January) recommended better targeting of antibiotics for suspected sepsis to ensure the right people receive treatment as soon as...
USA – FDA modernizing pharmacovigilance oversight with AI tools
To modernize its pharmacovigilance efforts, the US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) is using artificial intelligence (AI) to...
USA – FDA finalizes best practices guide for postmarketing safety studies
The US Food and Drug Administration (FDA) has finalized a guidance describing best practices for its staff in conducting postmarketing safety surveillance of marketed...
International – Regulators, industry tout new approach for benefits-risk assessments
Regulators and industry representatives said that a new international guideline for evaluating the benefit-risk profile of new and marketed drugs developed by the Council...
Europe – EMA proposes waiving comparative efficacy studies for certain biosimilars
The European Medicines Agency (EMA) is proposing to waive comparative efficacy studies (CES) for biosimilars with a straightforward mechanism of action (MOA), such as...
Europe – Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO)...
The EMA intends to migrate the Centrally Authorised Products (CAPs) and non-Centrally Authorised Products (non-CAPs) data held in the eXtended Eudravigilance Medicinal Product Dictionary...
USA – Clinical trials: FDA proposes new standards for collecting race, ethnicity data
The US Food and Drug Administration (FDA) is outlining a standardized approach for collecting and reporting on race and ethnicity data in clinical trials...
UK – Sobi receives NICE recommendation for Zynlonta in two non-Hodgkin lymphomas
The CD19-directed antibody-drug conjugate (ADC) has specifically been recommended for use in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or high-grade...
USA – FDA issues QMSR final rule with 2-year transition period
The US Food and Drug Administration (FDA) has published its long-awaited Quality Management System Regulation (QMSR) final rule that harmonizes its requirements with a...
Europe – Clinical trials’ transition to new EU system – one year left
All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. This date marks...
