Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more
The European Medicines Agency (EMA) published a workplan on its ambition to leverage high volumes of data and artificial intelligence (AI). On 7 May 2025, the European Medicines Agency (EMA) published a joint workplan with...more
Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more
Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI technologies rapidly evolve, global regulators face the complex task of regulating AI to...more
The European Medicines Agency (EMA) has finally joined the discussion on artificial intelligence (AI) and machine learning (ML), releasing a draft reflection paper on the use of these technologies throughout the medicinal...more