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ANDA Approval Times Get Optimistic Estimate In Budget Request

Executive Summary

US FDA has historically overestimated generic review performance in budget requests, but recently underestimated the number of ANDAs it expects to approve.

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After spike in March, generic drug application submissions drop 62% in April, while approval volume remains at monthly average.

Generic Drug First-Cycle Approval Rates Lagging Under GDUFA I

Only 8% of original ANDAs submitted in the user fee program’s third year were approved on the first cycle, compared with 72% that received a complete response letter.

ANDA Reviews: First-Cycle Desired, But Two-Cycles OK?

CDER Director Woodcock says it may not be necessary for the ANDA first-cycle approval rate to approach that for NDAs, but lowering the number of cycles to two would be desirable.

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