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Better Ways Needed to Track Drug Safety: Report
Date:5/1/2012

le records. Collecting this information in a single, publicly accessible format would show the FDA's commitment to this drug "life-cycle" approach and make the process more open, according to the report.

Among its other recommendations, the report also said the FDA should order postmarket studies only if: a regulatory decision cannot be made based on existing safety evidence; the research can sufficiently address concerns about a drug's benefit-risk balance to help lead to a regulatory decision; the results will be used to make a regulatory decision in a timely fashion; and the rights and interests of the research participants can be adequately protected.

In addition, the FDA should ensure that postmarket studies it orders are conducted in ways that are ethically and scientifically sound, the report said.

"Our report focuses on how the agency can be proactive so that situations in which a drug's benefit-risk profile becomes problematic can be detected earlier, and it details how FDA can get the additional information on a drug's safety in the most ethical and scientifically sound ways when questions arise," Faden noted in the news release.

Report committee co-chair Steven Goodman, associate dean for clinical and translational research at Stanford University School of Medicine, added: "We believe that the adoption of a life-cycle approach to drug approval and monitoring will help the agency strengthen its oversight, better tackle these complex decisions, and increase public confidence in the agency's ability to protect public health. This will become increasingly important as FDA looks for ways to safely expedite the drug-approval process."

More information

The U.S. Food and Drug Administration outlines how it manages drug safety issues.

-- Robert Preidt

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