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Seven Days In March: NDA-BLA and ANDA Approval Output Diverged As Coronavirus Teleworking Began

 
• By Derrick Gingery

New drug approvals dropped, likely because of a new focus on COVID-19 treatments, while generic drug approvals increased.

Machinery cogwheels, industry concept
The coronavirus outbreak forced changes to FDA workflow and priorities, which may have affected NDA-BLA approval output. • Source: Shutterstock

The US Food and Drug Administration's generic drugs program output has flourished since the coronavirus pandemic forced workflow alterations, while the new drugs program has suffered.

A seven-day stretch when the agency transitioned to mass telework corresponded with the slowdown in approval output in the Office of New Drugs as well as the boost in the...

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