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US FDA Preparing For Potential Bolus Of Complex Generic Applications

 
• By Derrick Gingery

Increasing number of product development meetings suggests that many complex generics remain in the development stages.

Wave building. Alamy
An increase in pre-submission meeting requests going forward could predict a complex generic application rush. • Source: Alamy

The complex generics workload at the US Food and Drug Administration remains largely slanted towards product development, but a bolus of applications is expected soon.

Nearly all of the meetings granted through the FDA pre-ANDA meeting program, which aims to help complex generics and some...

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