How Real-World Evidence
is Impacting Regulatory

Volume 1: A collection of 12 recent approvals based on RWE.

From the new FDA framework to the urgency of COVID-19, recent events have dramatically accelerated the use of RWE in regulatory decision-making. Now, life sciences organizations are investing heavily in analytics to generate RWE for regulatory submission.

This booklet compiles 12 recent cases where the regulatory decision for a new drug or label expansion was influenced by RWE.

In this booklet you will find out:

  • Background of drugs and reason for regulatory submission
  • How RWE was used and what impact it had on the decision
  • Regulatory approval and its impact on future decision-making