Elite Pharmaceuticals Inc (ELTP)

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FDA Makes No Indication That Guidance for Abuse-Deterrent Labeling Will Be Finalized in 2015

http://claad.org/fda-makes-no-indication-that-guidance-for-abuse-deterrent-labeling-will-be-finalized-in-2015/

Posted On 19 Jan 2015


Tag: abuse-deterrence, Food and Drug Administration

Despite Congress’s calls for the Food and Drug Administration (FDA) to finalize labeling guidance for the manufacturing of abuse-deterrent opioids, the federal agency has made no indications that it plans to publish regulations in 2015. The FDA released draft guidance in January 2013 amid the national prescription drug abuse epidemic and, in its year-end spending bill, Congress gave the FDA until June 30 to finalize it. Should the FDA miss the deadline, Congress will redirect $20 million of the agency’s budget to assist law enforcement efforts to reduce opioid misuse and abuse.