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21st Century Cures Bill Could Create More Prescriptive Rx Approval Standards For FDA

 
• By Sarah Karlin-Smith

Simplified and speedier drug approval process is focus for Reps. Upton and DeGette’s upcoming legislation – but getting there may mean more congressional micromanaging over FDA’s drug approval standards.

Reps. Fred Upton and Diana DeGette have offered a first peak at the concepts the pharma industry can expect to see in draft biomedical reform legislation known as the 21st Century Cures Initiative.

The legislation, expected to be released in January, will “streamline the approval of drugs,” Upton and DeGette said. But given...

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More from United States

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• By Sarah Karlin-Smith

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First Among Equals: US FDA CBER Director Prasad Gains Agency-Wide Authority

 
• By Bridget Silverman

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BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

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BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 
• By Sarah Karlin-Smith and Mandy Jackson

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More from North America

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
• By Bridget Silverman

US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.

US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
• By Bridget Silverman

Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.