US FDA Generic Drug Approvals, Other Actions Declined As Approval Times Climbed In FY 2024

An increase in complex product submissions may explain median and mean approval time increases for ANDAs, but fewer actions across many categories could be a concern.

Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medication.
The FY 2024 generic drugs activity data likely will inform user fee reauthorization negotiations, which will begin in 2025. • Source: Alamy

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