1. Pink Sheet

Senate Draft Bill On Opioids Tasks US FDA With Clarifying Its Regulation Of New Treatments

 
• By Cathy Kelly

Discussion draft released by Senate HELP Committee directs agency to hold at least one public meeting and issue four guidances on a range of issues.

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The US FDA would be responsible for clarifying its approach to regulating new non-addictive and non-opioid drugs for pain under draft legislation released by the Senate Health, Education, Labor and Pensions Committee April 4.

Through public meetings and guidances, FDA would be required to address issues ranging from designing clinical trials and use of expedited approval pathways to its

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