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FDA seeks to fuel new responses to opioid crisis

May 31, 2018
by Gary A. Enos, Editor
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The Food and Drug Administration (FDA) intends to spur development of a range of products that could assist in the effort to combat the opioid crisis, from treatments for opoid use disorder to non-addictive devices to relieve pain.

The FDA announced Wednesday that it is launching an innovation challenge modeled after past efforts such as a 2012 initiative that resulted in new approaches to treat end-stage renal disease. The agency will accept submissions from June through September for its consideration, with an announcement of selected products expected to occur in November.

The FDA could give “Breakthrough Device” designation to certain products, which would eliminate the need for a separate application for approval of these products. The challenge is open to products at any stage of development, from concept to testing.

“Despite recent advances in some of these areas, there are still many opportunities to advance new technologies and bring new products to market to meet this urgent public health need,” a news release from the FDA states.

The agency recently approved Lucemyra (lofexidine) as the first non-opioid option for relieving the challenging symptoms of opioid withdrawal.

The Summits for Clinical Excellence bring together thought leaders on cutting-edge topics in multi-day national and regional conferences. Summits on mindfulness, trauma, process addiction, and shame appeal particularly to private practice behavioral healthcare professionals. Other Summits address the national opioid crisis from a regional perspective and engage a diverse group of stakeholders.

June 25-26, 2018 Pittsburgh — The Opioid Crisis: The Clinician's Role and Treatment Practices

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