Adigens Health

FDA issued a new guidance for medical devices and RWE. Applicability extends to drug development, regardless of the focus.

Senior Manager in Epidemiology based in Ireland - opportunity of a lifetime to join a unique research organisation

Regulators are already approving ultra-targeted therapies on the basis of biological plausibility and tiny datasets. Payers, meanwhile, are being asked to fund them at scale – often with little idea what they will deliver in real-world practice. In the era of bespoke and ultra-targeted therapies, RWE can’t just mean a case series and a few registry plots. It needs to behave like a trial, even when no one is randomised.