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.
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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