FDA signals need for GCP compliance to accept foreign clinical trial data for regulatory review

The U.S. Food and Drug Administration says it will only consider clinical evidence generated outside the United States if the studies were conducted according to good clinical practice standards.

In addition to meeting GCP, the data must be relevant and suitable for regulatory decision‑making, meaning it should be directly applicable to the product under review.

This guidance was highlighted in the latest "This Week at FDA" briefing, which also noted the Senate hearing of the agency’s new commissioner nominee and the agency’s rule aimed at reducing animal testing.