ABSTRACT

After a drug company has discovered what appears to be an active drug in their drug discovery program, regardless of which type is utilized, the candidate drug can then pass to the next stage of the drug evaluation process. This step will involve interaction of the drug company with the governmental agency that has responsibility for this area, the Food and Drug Administration (FDA). Over the years, the role of the FDA in drug evaluation has evolved into three main areas: (1) truth in labeling, (2) toxicity, and (3) determination of ef' cacy.