The Data Safety Monitoring Board for the APPROVe study recommended that the study be stopped for safety reasons.

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Once the FAA decides the redesign is safe and meets federal safety requirements, only then will it approve the Dreamliner's return to the skies.

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The FDA may have felt pressure to approve Avandia two years later because safety problems were starting to show up with Rezulin.

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"We've moved a long way from the era when the bias was to approve even when there were questions of safety, " says Nissen.

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"We won't make a decision (to approve the facility's restart) unless we're satisfied that public health and safety will be protected, " Jaczko told reporters.

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