OFFICE OF INSPECTOR GENERAL THE FOOD AND DRUG ADMINISTRATION'S OVERSIGHT OF CLINICAL TRIALS: Daniel R. Levinson Inspector General

摘要

1. To determine the extent to which the Food and Drag Administration (FDA) conducted inspections of clinical trials from fiscal year (FY) 2000 to FY 2005. 2. To assess FDA's processes for inspecting clinical trials. The Federal Food, Drug, and Cosmetic Act generally requires all new drags and medical devices (hereinafter referred to as investigational products) to undergo clinical trials on human subjects to demonstrate the safety and efficacy of these products before they are approved for sale in the United States. The sponsors, clinical investigators, and institutional review boards (TRBs) that conduct and oversee these trials must comply with FDA regulations designed to protect the human subjects participating in them. The Office of Inspector General (OTG) received a congressional request to review FDA oversight of clinical trials after a series of news articles highlighted vulnerabilities.