US Patient Medical Information Rule: Will It Be Delayed Again?

FDA originally proposed mandatory patient labeling in 1980 only to have the rule withdrawn by the incoming Reagan Administration; thirty-five years later, US agency is finalizing a proposed rule on the same topic. Will history repeat itself?

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The US FDA’s four-decade long effort to mandate distribution of a patient-friendly drug information sheet with each prescription could be facing yet another delay as part of the Trump Administration regulatory freeze.

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