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Opioid Prescriber Education Program May Become Mandatory; FDA Cites Failures In Voluntary System

 
• By Brenda Sandburg

US regulators set public workshop on benefits, challenges, and unintended consequences of making REMS education program mandatory. Having a single source for education is also being evaluated. Agency has previously been concerned that a mandatory program might require a restricted distribution system.

Opioid Rx
Opioid prescribers may have to participate in mandatory education program • Source: Alamy

The voluntary program to educate opioid prescribers about the appropriate use of painkillers has failed to curb the number of excess prescriptions and opioid overdoses, so the US Food and Drug Administration is considering making it mandatory.

The agency explained its shifting view on prescriber education in a Federal Register notice, to be published on 9...

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UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
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• By Eliza Slawther

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