The US Food and Drug Administration was “thrilled” when the European medicines regulatory network –comprising the European Medicines Agency, the European Commission and national competent authorities – released its multi-annual workplan, because it showed “alignment in where the FDA and EMA were going,” according to Tala Fakhouri, associate director for data science and AI policy at the FDA.
US FDA Heading In ‘The Same Direction’ As EMA On AI In Drug Development
Global regulators should work together on producing standard terminology around the use of AI in drug development to align as much as possible on their approaches, according to the Food and Drug Administration’s Tala Fakhouri.
