Enhancing Transparency at the US Food and Drug Administration Moving Beyond the 21st Century Cures Act

• Autores: Joshua M. Sharfstein, Michael Stebbins
• Localización: JAMA: the journal of the American Medical Association, ISSN 0098-7484, Vol. 317, Nº. 16, 2017, págs. 1621-1622
• Idioma: inglés
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• Resumen

  • The US Food and Drug Administration (FDA) has primary responsibility for oversight of every drug, biologic, and medical device sold in the United States. Yet the FDA is far more than a regulator. It is also an agency dedicated to public health, with the expertise of thousands of scientists and access to enormous amounts of information from clinical trials and other studies. Greater transparency can allow FDA not only to better meet its many obligations but also to advance the scientific enterprise needed to develop safe and effective medical products.