Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
Dr. Jayanta (Jay) Bhattacharya, nominated to be Director of the National Institutes of Health (NIH), and Dr. Martin Makary, nominated to be the Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look...more