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US FDA Orphan Exclusivity Would Revert To Pre-Catalyst Status Under Senate Legislation

 
• By Derrick Gingery

Federal court decision said the FDA cannot grant orphan exclusivity for subpopulations of a disease, which agency officials fear could damage pediatric rare disease drug development.

Drugs and judge's gavel
A court ruling denies FDA from awarding orphan exclusivity for population subsets, such as adults or children. • Source: Shutterstock

Catalyst Pharmaceuticals, Inc.’s court victory, which scrambled the US Food and Drug Administration’s orphan drug exclusivity policy, could be undone in upcoming user fee reauthorization legislation.

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Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.

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AI Could Be Used ‘In The Deliberation’ Of HTA Reviews In England, Says NICE

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.

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