US FDA Preparing For Potential Bolus Of Complex Generic Applications

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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