ANDA Approval Records Will End As US FDA Mops Up Backlog

 
• By Derrick Gingery

CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.

Businessman looking through a magnifying glass to documents
Once the backlog is cleared, there may be fewer ANDAs for FDA to approve, which may mean records will not continue to be broken each year. • Source: Shutterstock

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