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