Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024
EMA’s safety committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid (nirmatrelvir, ritonavir) when used...
Europe – Progress update on pilot for academic and non-profit developers of advanced therapy...
The aim is to guide non-commercial developers of promising ATMPs addressing unmet medical needs through the regulatory and scientific requirements in the European Union...
UK – Brainomix’s AI-enabled stroke software endorsed by NICE
The National Institute of Health and Care Excellence (NICE) has issued guidance endorsing the use of Brainomix’s artificial intelligence (AI)-enabled software, Brainomix 360, to...
UK – Illegal medicines worth more than £30 million seized in the UK in...
This includes more than two million doses seized during Operation Pangea, the international initiative of global enforcement partners that targets the illegal internet trade in medical...
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...
