USA – FDA issues new draft guidance on data monitoring committees
The US Food and Drug Administration (FDA) on Monday issued a new draft guidance advising certain product sponsors to establish data monitoring committees (DMCs)...
Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and...
Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented...
Europe – Evaluation of medicinal products indicated for treatment of bacterial infections
This guideline merges, revises and adds to the guidance previously included in the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev...
UK – NICE recommends STADA and Calliditas’ Kinpeygo to treat rare kidney disease IgAN
Affecting approximately 14,000 people in England, IgAN occurs when IgA accumulates in the kidneys, causing inflammation and scarring, which can lead to kidney failure.
Patients...
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...
