FDA Introduces 'Nonclinical Tests' Term, Signaling A New Beginning

To prove that a drug is safe enough to advance to human trials, laws in the United States have empowered the Food and Drug Administration for more than 60 years to require that clinical trial sponsors submit data from preclinical testing operations. Recently, however, the Food and Drug Omnibus Reform Act (FDORA) replaced the term “preclinical tests” with the term “nonclinical tests” to encourage the use of alternatives to animal testing, not eliminate animal testing altogether.

According to the law, the new term is defined as “a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug.”

As in other new clinical development advancements, discover how this change will require the investment of time and resources to deliver on its full potential.