FDA releases guidance to clarify use of clinical trial data collected outside US

The U.S. Food and Drug Administration released draft guidance on clinical trial data in an effort to make it easier to apply data collected abroad in the United States.

The guidance highlights 74 considerations that apply when using data collected outside the U.S. (OUS).

"FDA believes that promoting greater clarity concerning FDA's use of OUS data will reduce unnecessary duplication, further efforts to harmonize global clinical trial standards, and promote public health and innovation," the guidance states.

In addition, the FDA says the guidance will not complement and not supercede previous device guidance documents. Guidance