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Califf Suggests Congress ‘Tighten Up Laws’ To Address Orange Book Abuses

 
• By Sarah Karlin-Smith

US FDA Commissioner repeats longstanding FDA policy that the agency doesn’t have much power to address frivolous patent listings in the Orange Book, but seems to support Congress providing more authority.

FDA Commissioner Robert Califf
FDA Commissioner Robert Califf testified at the House Oversight Committee on 11 April. • Source: Screenshot

To take more aggressive action against patent tactics used to thwart generic competition, Congress should work with the US Food and Drug Administration and Patent and Trademark Office to craft legislation, FDA Commissioner Robert Califf said.

While testifying at the House Oversight Committee on 11 April, Califf was pressed by Rep

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England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
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