Citing safety, competition and national security, federal regulators and legislators have been increasing their scrutiny of clinical trials conducted in China and other non-U.S. jurisdictions. Companies that intend to leverage data from ex-U.S. studies must be aware of how a changing landscape may affect expectations and consider associated compliance obligations.

This webinar will discuss multiple arenas of current activity, including: 

• FDA’s Expedited IND pilot program to streamline the time for initiation of first-in-human clinical studies in the U.S.; 
•  proposed amendments to user fees to incentivize U.S. development; 
• implementation of the BIOSECURE Act and the U.S. Department of Justice’s Data Security Program, which limit certain procurement and transactions involving companies or countries of concern;
• proposed extension to biotechnology of business transaction notification and screening requirements under the Comprehensive Outbound Investment National Security Act (COINS Act) or Department of Treasury regulations;
• Congressional committee efforts to limit FDA’s acceptance of and reliance on data from clinical studies conducted in China; and
• Congressional investigation of sponsors that have conducted research in locations raising arguable military or human rights concerns.

For questions, contact Ella Peek.