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FDA To ANDA Sponsors: Don't Forget Quality When Rushing For 10-Month Review Goal

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency discusses potential bolus of applications in new fiscal year.

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FDA Rolls Out Zero-Tolerance Policy On ANDA Typos

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.

FDA Rolls Out Zero-Tolerance Policy On ANDA Typos

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.

ANDAs Can Get Priority, Eight-Month Reviews Under User Fee Deal

GDUFA II gives certain generics the possibility of an even faster review clock, which burnishes FDA's credentials in the drug pricing debate, but in order to take advantage, applications will need to be of high quality in addition to addressing a public health priority.

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