How Real-World Evidence
is Impacting Regulatory
Volume 3: A collection of 10 recent regulatory decisions
based on RWE.
In Volumes 1 and 2 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 3, we offer 10 more recent cases of life sciences companies investing in RWE and using it in submissions to the FDA and other regulatory agencies. Not just using it – but using it successfully.
This volume includes examples from oncology, hematology, neurology, genetics, dermatology, and more.
In this booklet you will find out:
- Regulatory guidance on RWE including the FDA RWE framework
- 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