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.

FDA wants to improve the ANDA first-cycle approval rate, but Janet Woodcock said cutting the number of cycles to two would be a desirable near-term goal for the Office of Generic Drugs.

Rather than pushing for first-cycle approvals, Woodcock, director of FDA’s Center for Drug Evaluation and Research, suggested during the June Generic Pharmaceutical

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