The use of Real-World Data (RWD) to support regulatory decisions is growing rapidly.
Several regulating agencies have in the past few years issued guidelines on the requirements on Real-World Evidence (RWE)-studies to be fit-for purpose for regulatory purposes.
Nordic data properties share many attributes, such as availability of key data elements, high data accuracy and almost universal completeness, highlighted by the recent FDA-guideline as key elements for RWD to be considered fit-for-use in regulatory decision making.
It is therefore no surprise that Nordic data has been used in FDA decision making:
· FDA 510(k) K173860 – Volcano, an imaging system used in coronary artery disease – Swedish Coronary Angiography and Angioplasty Registry, SWEDEHEART, Danish National Patient Registry and the Western Denmark Heart Registry used to evaluate the effectiveness of Volcano in coronary revascularization decision-making
· FDA DEN140010 – The Danish Newborn Screening Biobank was used to collect blood spot samples to establish clinical cut-off values for an in vitro diagnostic device, a test to screen newborns for severe combined immunodeficiency disorder (SCID). The performance of the device was evaluated using Danish medical records to confirm that the newborn had not died from SCID related complications (or had been associated with SCID) at one-year.
Are you interested in knowing more about how Nordic RWD can be used in regulatory decision making? Don’t hesitate to reach out!
