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Growing Complex Generic Application Load May Force US FDA Staffing Changes

 
• By Derrick Gingery

Complex products are slowly gaining a larger share of ANDA submission and approval totals, which could mean the FDA has to adapt its in-house expertise to compensate.

Glucagon kit
FDA research helped clear a pathway for approval of a generic glucagon product. • Source: Alamy

Complex products are slowly gaining an increasing share of generic drug applications, but the US Food and Drug Administration still feels there is time to plan for staffing and other potential changes that may be needed.

Complex generics eclipsed 13% of all ANDA approvals in fiscal year 2021, the latest accounting of a steady rise since at least FY 2017. (See charts at end of story.)

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