AN EXAMINATION OF THE DRUG REVIEW PROCESS WITHIN THE UNITED-STATES

A general overview of the drug review process is presented with emphasis on non-clinical approaches for gaining acceptable exemptions for investigational use of new drugs. Selected non-clinical requirements for approval of marketing or the new drug application are also discussed. Particular attention is given to the trend towards a more rational, scientific approach to the design of studies that are intended to elucidate issues of safety and efficacy. The fundamental purpose of these new approaches is to reduce drug development time and expense and bring newer and better drug therapies to patients. Newer requirements for the conduct and use of kinetics earlier in development are emphasized. The relevance of meetings with the Food and Drug Administration and the effects that meetings are reported to have had on total drug development time are also discussed.