US FDA Doesn’t Want ANDAs With Facilities Not Ready For Inspection Even Though It Can Accept Them

 
• By Derrick Gingery

An agency official said the GDUFA III provision hopefully will be used for only a small number of ANDAs. We chart the approval times and first-cycle clearances over the course of the generic user fee program.

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One of the priorities in GDUFA III is to reduce the number of assessment cycles needed to gain approval • Source: Shutterstock

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