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. Pink Sheet charts the approval times and first-cycle clearances over the course of the generic user fee program.

generic drugs
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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