EU Pharma Wants Regulators’ Help To Simplify Digital Endpoints Landscape
The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.
You may also be interested in...
EU drug regulators have received some candid responses from trial sponsors and other stakeholders on the aspects that should be urgently addressed in the next iteration of their guidance on decentralized clinical trials.
AI initiatives in a country known for its software prowess, along with startup support, clinical trial rule changes, crunched approval timelines, unified digital regulatory interfaces and a R&D policy laying out $600m in funds, are all meant to build something greater than the sum of its parts. In a bottom-up approach, India is building an innovation ecosystem
The European Medicines Agency has been on a steep learning curve with its qualification of a digitally-measured outcome for use in Duchenne muscular dystrophy trials, smoothing the way for other developers entering the digital biomarker space.