Lexology June 14, 2024
Jones Day

Building on CDER’s efforts to modernize clinical trials, C3TI will support innovative approaches to clinical trial design and conduct.

In April 2024, the U.S. Food and Drug Administration (“FDA”) Center for Drug Evaluation and Research (“CDER”) announced the launch of the Center for Clinical Trial Innovation (“C3TI”) to support innovative approaches to clinical trials designed to improve drug development efficiency through enhanced communication and collaboration.

C3TI will primarily serve as a “central hub” to:

  • Facilitate sharing of lessons learned across CDER’s existing clinical trial innovation programs.
  • Serve as the single CDER point of contact to support non-product-specific questions about clinical trial innovation.
  • Support knowledge-sharing through discussion forums, public workshops, communications, and a knowledge repository consolidating information on CDER’s clinical...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

Continue Reading

 
Topics: Clinical Trials, FDA, Govt Agencies, Trends
Related Articles:
FDA warns GLP-1 compounder over safety rules
GLP-1 drug approvals: A breakdown
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
FDA approves Novo Nordisk's Ozempic to treat chronic kidney disease in those with diabetes, expanding its use
Certainty vs. speed: How do patients feel about the tradeoff for new cancer drugs?

Share This Article