A designation granted by FDA’s Center for Drug Evaluation and Research following completion of a drug development program consisting of extensive pre-clinical trials, rigorous placebo-controlled clinical studies, numerous safety studies and submission of a new drug application. FDA drug approval guides correct dosing, safety, and efficacy of new compounds for medical use. Demonstration of product consistency is also required for FDA approval.« Back to Glossary Index
Overdose Word of the Week
Drug diversion is a medical and legal concept involving the illegal movement, adulteration, marketing, or transfer of any legal controlled substance anywhere within the supply chain; from manufacturer to end user.