FDA Aims To Bolster Oversight Of Drug Safety Data

Law360, New York (January 18, 2008, 12:00 AM EST) -- The U.S. Food and Drug Administration is set to hold a public workshop to examine methods of collecting and reporting data about drugs’ side effects in a bid to address widespread criticism over its failure to recognize emerging drug safety issues in a timely manner.

The workshop, “Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle,” is slated for Jan. 29.

It aims to solicit information on research approaches and methods associated with the best ways to assess the public...
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