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PDUFA VII: US FDA Says Money Can’t Solve Meeting Problems

 
• By Derrick Gingery

Mid-cycle meeting for some supplements cannot be accommodated without extending the goal date, the agency tells industry negotiators.

Many clocks in a vending machine to illustrate the importance and fleeting nature of time and the desire to buy more and make a moment last longer - Illustration
The FDA said time, not money, is the issue with adding a mid-cycle meeting for prior approval manufacturing supplements. • Source: Shutterstock

More user fee money cannot buy sponsors additional meetings with the US Food and Drug Administration for some application supplements.

That the message from agency officials during negotiations of the next prescription drug user fee program cycle. The FDA proposed...

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PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 
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More from Pathways & Standards

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

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