Compassion vs Control: FDA Investigational-Drug Regulation
نویسنده
چکیده
Victims of AIDS and other incurable diseases are denied access to potentially valuable experimental drugs by the U.S. Food and Drug Administration. Under the present law, no new drug or medical device can be sold until it has been approved as safe and effective" by the FDA. New-drug approval is an expensive process that routinely takes years to complete. Unapproved experimental products cannot be given to human subjects except in investigational studies that have been explicitly pre-approved by the FDA through a process known as "application for investigational drug (IND) exemption."
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