Generic drug sponsors be forewarned: ensure the application is sufficiently proofread before it is filed.
The US FDA will not offer any sympathy for typos in ANDAs if they cause a major deficiency, such as...
FDA Rolls Out Zero-Tolerance Policy On ANDA Typos
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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.
Learn what's happening at the US FDA. On the go.
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