Search Results for Abuse-Deterrent Opioids

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FDA to Take Closer Look at Abuse-Deterrent Opioids By Michael Mezher - Published 13 June 2017

The US Food and Drug Administration (FDA) on Tuesday announced its next move in addressing the ongoing opioid abuse epidemic will be to take a closer look at the data supporting abuse-deterrent labeling for opioids.

Categories: News, US, Drugs, Labeling, Postmarket surveillance

Tags: Opioids, Abuse-Deterrent Opioids

FDA Finalizes Approach to Abuse-Deterrent Opioids By Alexander Gaffney, RAC - Published 01 April 2015

Federal regulators have at long last finalized a policy which establishes voluntary guidelines by which manufacturers of opioid-based painkillers can prove that their products are resistant to misuse and abuse by patients.

Categories: News, US, CDER, Clinical, Drugs, Labeling, Postmarket surveillance

Tags: Opioids, Abuse-Deterrent Opioids, Guidance, Final Guidance

FDA to Publish Biosimilars Labeling, Generic Opioids Guidance Later This Year By Alexander Gaffney, RAC - Published 27 February 2015

US pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs.

Categories: News, US, CDER, Biologics and biotechnology, Generic drugs, Prescription drugs

Tags: Biosimilar, Biosimilar Labeling, Opioids, Generic Opioids, Abuse-Deterrent Opioids, Guidance, Draft Guidance