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March 7, 2017

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

Author Affiliations
  • 1Johns Hopkins Bloomberg School of Public Health, Department of Health Policy and Management, Baltimore, Maryland
JAMA. 2017;317(9):905-906. doi:10.1001/jama.2017.0918

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.

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