Using Real-World Evidence for Label Expansions

The use of RWE to support product label expansion has been a primary driver of interest in RWE. The 21st Century America Cures Act, enacted in 2016, required FDA to evaluate RWE in support of new drug indications. Since the Cures Act, FDA has issued multiple guidances and draft guidance statements regarding use of RWE for regulatory applications. The Agency has also utilized RWE in approving expanded indications for drug products. As FDA states at the top of its RWE web page, “Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.”

This virtual presentation will focus on 3 aspects of RWE:

1)    What are RWE and Real-World Data (RWD), and how are they different?

2)    What are relevant legal and regulatory considerations associated with using RWE for product label expansion?

3) How have applicants successfully used RWE to obtain approval for new drug and medical device indications?