Prompted by criticisms of long delays in its drug approval processes, the Food and Drug Administration (FDA or the Administration) took a number of measures in recent years to expedite access and increase availability of new drugs for terminally ill patients. These reforms began in the late 1980s, as acquired immune deficiency syndrome (AIDS) advocacy organizations openly criticized the FDA, noting that its policies were insufficient to address the prevalence of AIDS and the lag time for FDA approval of new AIDS treatments. The FDA's primary responsibility is to promote efficacy and ensure safety of new drugs. Consequently, the FDA must balance patients' desires to obtain new medications to treat serious and lifethreatening illnesses against government's desires to protect patients from abuses of the new drug approval process. The structure of the FDA's regulatory procedures is, therefore, essential to providing safe, effective medical treatments to patients. FDA regulations and guidelines set forth standards and practices that pharmaceutical companies must follow to gain approval of newly developed drugs.