An investigational new drug application (INDA)is submitted _____ trials.

Question

Quizplus · Accepted Answer

Preclinical testing usually lasts about 3 years.After the preclinical trials have been completed,an INDA must be filed with the FDA before a drug company can commence phase 1 clinical trials.Animal testing data must be accumulated from preclinical trials before filing an INDA.Phase 1 is the first trial using patients,and phases 2 and 3 follow phase 1.An INDA must be filed before any testing in humans can commence.

An Investigational New Drug Application (INDA)is Submitted _____ Trials