How Real-World Evidence
is Impacting Regulatory

Volume 4: A Collection of 12 Recent Regulatory
Decisions Based on RWE

In Volumes 1, 2, and 3 of How Real-World Evidence is Impacting Regulatory Decision Making, we provided examples of the growing use of RWE in regulatory agency submissions. These first three volumes highlighted the ways in which RWE was integral in bringing important new therapies to market. First time therapies for rare diseases like Tazverik for treating patients with epithelioid sarcoma, Besremi for polycythemia vera PV that patients can take regardless of their treatment history, and Koselugo, for the treatment of Neurofibromatosis type 1, an incurable, rare and debilitating genetic condition, all included significant RWE in their applications for approval.

In volume 4, we look at 12 more use cases including approvals and expansions in areas including immunology, neurology, psychiatry, cardiovascular, and more. Fill out the form to download this booklet to see how life sciences organizations are increasingly relying on RWE to bolster regulatory submissions.

Lab + Claims RWE: A Game Changer for RWE in Healthcare

This solution combines the industry leading IHD Analytics platform with MMIT’s integrated laboratory data and Med/Rx claims data to provide a game changer in healthcare analytics.