FDA rule may protect firms from disclosure lawsuits

08/22/2008 | Bloomberg

The FDA issued a rule that limits revisions made to product warnings by drug and medical-device makers. The rule clarifies long-standing FDA policy and allows companies to add information to labels before a complete FDA review in particular cases. An agency official said the move would clarify and "provide additional confidence to patients and doctors that information on medical-product labels has a sensible scientific basis."

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