As policy makers and regulators consider how best to incorporate the use of of real-world evidence (RWE) and real-world data (RWD) for changes to the label of an approved product, The Biotechnology Innovation Organization (BIO) has prepared a white paper to offer the perspectives of BIO member companies.
The White Paper provides the BIO membership perspective regarding the use of real-world evidence (RWE) and the underlying real-world data (RWD) for inclusion within the label of an approved product, including the addition of new indications for already approved products.
RWE can provide additional types of clinical information that informs decision-makers and speeds access of medical products to patients.
To access the white paper, click the image at right.