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Abuse Deterrence: US Exclusivity Update May Ride User Fee Coattails

 
• By Derrick Gingery

CDER's Woodcock suggests exclusivity rules outdated for abuse-deterrent technology development, and Rep. Griffith takes it to mean legal changes are needed.

Bottles

Rx product exclusivity laws, as they relate to abuse-deterrent formulations of pain treatments, seem ripe for adjustment in the upcoming user fee legislative package to better encourage product development in the US.

Rep. Morgan Griffith, R-Va., asked Center for Drug Evaluation and Research Director Janet Woodcock during a recent hearing on the prescription drug user fee reauthorization whether it was accurate that...

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Samsung Bioepis Heads For Spin Out To Unlock ‘Hidden Value’

 
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Amgen And Samsung Soliris Biosimilars Skirt UK Infringement On Claim Construction

 
• By Dean Rudge

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