Gottlieb Initiative Will Expedite Device, Drug Pain Control Alternatives, FDA Chief Says
US FDA Chief Scott Gottlieb said he will soon announce an initiative to help expedite approvals of both innovative devices and drugs that are designed to control pain as an alternative to opioid prescriptions commonly written by doctors.
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Echoing President Trump's ongoing call to fight the opioid-abuse epidemic, the US agency is asking medtech companies to submit applications for new products to tackle the issue. Promising devices and diagnostic tools identified by the agency will get extra attention from FDA, but they won't have to submit an additional application for a Breakthrough Device designation.
The Senate Health, Education, Labor and Pensions (HELP) Committee and House Energy and Commerce Health Subcommittee each passed bills this week to expedite approval pathways for non-opioid devices and drugs to control pain and prevent further addictions. Other opioid bills passed by the House subpanel seek to remove reimbursement challenges for opioid-alternative pain control devices.
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