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US FDA orders classwide REMS for long-acting opioids

 
• By Sue Sutter

The US FDAis requiring 16 manufacturers of 24 branded and generic opioid medicines to jointly develop a classwide risk evaluation and mitigation strategy (REMS) to reduce deaths and serious injuries resulting from misuse, abuse and overdose.

The US FDAis requiring 16 manufacturers of 24 branded and generic opioid medicines to jointly develop a classwide risk evaluation and mitigation strategy (REMS) to reduce deaths and serious injuries resulting from misuse, abuse and overdose.

When implemented, the programme will represent the largest, most far-reaching REMS to date under the FDA Amendments Act's drug safety provisions, affecting more than 21 million prescriptions annually. The agency's...

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In Brief: US FDA Delay Sends Biohaven Shares Down

 
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The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

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