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
The Coronavirus (COVID-19) pandemic poses an acute health risk to the population. One key to successfully combating COVID-19 lies in clinical research. Currently, almost all major research-based pharmaceutical companies, many...more
While several drugs are being studied in Japan to treat COVID-19, none have yet been approved. However, reports indicate remdesivir, a drug developed by as a treatment for Ebola virus disease, has been administered as a...more
In response to the outbreak of a pneumonia-like disease caused by coronavirus (COVID-19), Chinese regulatory authorities adopted a few emergency measures under certain “Special Review and Approval Procedures” to fast-track...more