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FDA Announces Changes to Safety Labeling Requirements for Opioid Medications

The U.S. Food and Drug Administration has announced that changes to safety labeling requirements for opioid medications are receiving final approval and implementation. These changes are part of the agency’s ongoing efforts to address the country’s opioid overdose epidemic, a crisis that has taken tens of thousands of American lives over the past several decades and is still one of the most prolific killers in the country.

The changes were first announced in April 2023 when the FDA notified application holders of Abbreviated New Drug Applications (ANDAs) and New Drug Applications of…

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