Report: FDA should implement life-cycle approach to oversee drugs

The FDA should oversee approved drugs on an ongoing basis to address post-market issues that will affect a medication's benefit-risk profile, according to a report issued by the Institute of Medicine. The IOM committee also said that health IT and analytics advances "likely will mean that observational approaches using large data sets will become more important over time."

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IOM urges life-cycle approach' on drug monitoring - Modern Healthcare (subscription required) · U.S. needs better way to track drug safety - study - Reuters

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