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FDA Will Not Review New Applications During Government Shutdown

 
• By Brenda Sandburg

The agency is not accepting regulatory submissions that require an FY 2014 user fee payment during the shutdown; of the 8,180 FDA employees now reporting to work, 74% are funded by user fees.

The government shutdown on Oct. 1 has forced FDA to close its doors to new applications, limiting its review to those already on file.

In response to questions about the impact of the shutdown on agency activities, FDA said that it will not have...

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US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

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Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 
• By Bridget Silverman

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Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

 
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