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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. Download the booklet to 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