The European Medicines Agency has finalized its reflection paper on a tailored clinical approach to biosimilar development, revising the wording on when it may waive the need for comparative efficacy ...

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 ...