On April 1, 2025, the European Medicines Agency opened the consultation period for its draft reflection paper on a tailored clinical approach in biosimilar development. The reflection paper considers ...
The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it. The European Medicines Agency (EMA) published a draft reflecting paper ...
EMA's draft reflection paper promotes using patient experience data in drug regulation to enhance decision-making processes. Patient perspectives, such as quality of life, complement scientific data ...