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‘Real World’ Opioid Abuse Data On OxyContin Again Under Review At US FDA

 
• By Kate Rawson

Resubmission comes more than four years after Purdue pulled an sNDA seeking to demonstrate ‘real-world’ abuse prevention.

Purdue Pharma LP has submitted all required post-marketing studies on the real-world use of OxyContin (extended-release oxycodone) to the US Food and Drug Administration and the data are once again under review.

That was a surprising bit of news to come out of the 15 January Anesthetic and Analgesic Drug Products and...

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
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The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
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UK And US Regulators In Sync On RWD External Control Arms

 
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The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

More from Clinical Trials

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

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Pharma Companies Suspecting Clinical Trial Fraud Should Move Quickly, Quietly

 
• By Sue Sutter

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.