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.

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