drug approval;
economic competition;
medical economics;
United States food and Drug Administration;
D O I:
10.1177/106286060201700603
中图分类号:
R19 [保健组织与事业(卫生事业管理)];
学科分类号:
摘要:
The Food and Drug Administration (FDA), in its review of pharmaceuticals for safety and effectiveness, has relied heavily on placebo-controlled studies. In their prescribing practice, physicians often face clinical decisions between several FDA-approved drugs for the same indication, with little guidance from the FDA on the similarities or differences of the drugs. The public could benefit if the FDA were more proactive in declaring, when applicable, that the best available evidence does not indicate any significant clinical advantage for a particular FDA-approved drug compared with others.
机构:
Universitätsklinik für Klinische Pharmakologie, Medizinische Universität Wien, Wien
Universitätsklinik für Klinische Pharmakologie, Medizinische Universität Wien, 1090 WienUniversitätsklinik für Klinische Pharmakologie, Medizinische Universität Wien, Wien