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Conflict of Interest Reform: Greatest Impact May Be Committee Vacancy Rate

 
• By Derrick Gingery

FDA user fee reauthorization eliminates limits on waivers, which may ease the burden on FDA to fill open seats on its advisory committees. Vacancy rates have been as high as 24% in FY 2012.

The FDA user fee reauthorization loosens conflict of interest rules for advisory committees, but may not actually result in a substantive change in agency practices.

Its biggest impact may be to boost the overall number of FDA advisory committee members, as the adjusted rules could

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More from United States

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• By Jessica Merrill

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• By Derrick Gingery

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• By Sue Sutter and Bridget Silverman

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Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

More from North America

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By Kate Rawson

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Trump Administration Push For Dismissal, Transfer Of Mifepristone Case Leaves Overhang For Pharma

 
• By Sarah Karlin-Smith

The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.