ANDA Approval Records Will End As US FDA Mops Up Backlog

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

The US Food and Drug Administration's record generic drug approval numbers in recent years was partially a function of a large application backlog, according to Center for Drug Evaluation and Research Director Janet Woodcock.

As a result, the annual record setting for ANDA approvals "probably not going to last," as the agency approves the remainder of the existing backlog, Woodcock said on 3 December.

ANDA Approval Records Will End As US FDA Mops Up Backlog

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