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Approval Of New Drugs By The U. S. Food And Drug Administration: Problems With The Process And Access To Unapproved Drugs, Christine M. Hoeft-Loyer

Master's Theses and Doctoral Dissertations

Today, the vast majority of drugs available for patient use have gone through a rigorous system of human clinical trials supervised by the Food and Drug Administration (FDA), to ensure the drugs are safe and efficacious. There are now citizen advocacy groups that seek use of drugs not yet approved by the FDA, to be administered to terminally ill patients who have exhausted all other available means of therapy. The FDA has programs for terminal patients, under the supervision of their physicians, to use unapproved drugs; however, the advocacy groups seek access to drugs in much earlier phases than is …