The European Medicines Agency and Publication of Clinical Study Reports A Challenge for the US FDA

• Autores: Anna L. Davis, James Dabney Miller
• Localización: JAMA: the journal of the American Medical Association, ISSN 0098-7484, Vol. 317, Nº. 9, 2017, págs. 905-906
• Idioma: inglés
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• Resumen

  • The US Food and Drug Administration (FDA) has been the standard of drug regulation worldwide for decades. In 1962, in response to the thalidomide tragedy, Congress directed the FDA to evaluate the effectiveness of drugs based on “adequate and well-controlled investigations, including clinical investigations” conducted by qualified experts.

    Backed by this congressional enactment, the FDA crafted groundbreaking administrative regulations (eg, the requirements of a prespecified protocol, placebo or active controls, the phasing of clinical investigations, and informed consent from patients) that have guided the global clinical trial enterprise ever since.1 The FDA’s regulations revolutionized the evaluation of drugs in the United States and abroad.