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News From the Food and Drug Administration
May 5, 2015

Final Guidance Issued on Abuse-Deterrent Opioids

JAMA. 2015;313(17):1704. doi:10.1001/jama.2015.4112

The Food and Drug Administration (FDA) has issued a final guidance document to provide manufacturers with a framework for evaluating and labeling abuse-deterrent opioids. Congress had threatened to cut the FDA commissioner’s budget by $20 million if the agency did not finalize its January 2013 draft document by June 30 (http://1.usa.gov/1NKgeFl).

Opioids formulated with properties intended to deter abuse represent a potentially important step toward making them safer, according to an announcement in the Federal Register (http://bit.ly/1bQf8dJ). “FDA considers development of these products a high public health priority,” the announcement noted.

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