Want To Avoid A Refuse-To-File? Submit ANDA In English, FDA Says
Generic applications continue to be tripped up by failing to adhere to other well-known standards such as paying user fees, US agency says.
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Performance numbers are likely to fluctuate over the course of the program, but the rate of first-cycle approvals during the first month of the new user fee program is more than double the rate during the last year of the old iteration.
In another show of force on generic drug application quality, US agency says it will not accept applications with major deficiencies caused by a typographical error, even if the sponsor corrects it.
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.