How Real-World Evidence
is Impacting Regulatory

Volume 2: 12 recent approvals based on RWE.

In Volume 1 of How RWE is Impacting Regulatory Decision-Making, we outlined cases where real-world evidence impacted the approval of a new drug or label expansion of an existing one. In Volume 2, we offer 12 new use cases of life sciences companies continuing to invest in RWD to advance product approvals before an FDA that is only becoming more accepting of 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