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Could PDUFA VIII Align With Trump’s Efficiency Emphasis?

 
• By Sue Sutter

Given the Trump Administration’s intense focus on cutting costs and increasing efficiency, industry and the FDA should focus on what is and is not working in PDUFA VII when negotiating the next agreement, lobbyists said at the BIO CEO and Investor Conference.

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PDUFA VIII negotiations offer a chance to align the FDA's user fee program with the Trump Administration's focus on efficiency, lobbyists said. (Shutterstock)
Key Takeaways
  • The next prescription drug user fee negotiations are a chance to streamline the FDA’s drug review activities, aligning with the Trump Administration’s focus on efficiency and cutting costs, lobbyists said.

Upcoming negotiations to reauthorize the US Food and Drug Administration’s prescription drug user fee program should be viewed as a...

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• By Sue Sutter

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• By Sue Sutter and Derrick Gingery

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• By Sue Sutter

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• By Sue Sutter

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• By Sue Sutter

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