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Senate Bill Seeks to Speed Fast-Track Options for Opioid Alternatives
In the latest addition to the swirl of opioid-related bills circulating on Capitol Hill, four senators introduced legislation to require the FDA to issue guidance on how breakthrough and accelerated approval designations apply to novel, non-opioid or non-addictive pain medications.
The approval process for breakthrough therapy and accelerated approval designations is unclear for opioids and addiction treatments, according to the bill’s sponsors — Sens. Orrin Hatch (R-Utah), Joe Donnelly (D-Ind.), Todd Young (R-Ind.), and Michael Bennet (D-Colo.).
Hatch said the bill would cut red tape to ensure manufacturers of non-opioid pain medications can bring them to market as quickly as possible.
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