FDA Rolls Out Zero-Tolerance Policy On ANDA Typos
Executive Summary
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.
You may also be interested in...
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.
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.
Manufacturers' Data Integrity Problems Remain FDA Investigators' Focus
US FDA official warns the pharmaceutical industry that investigators will continue to look for data integrity problems during inspections, and discusses “red flags” observed in inspections.