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Want To Avoid A Refuse-To-File? Submit ANDA In English, FDA Says

 
• By Derrick Gingery

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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Some of the seemingly simplest mistakes continue to trip up generic drug sponsors, forcing ANDAs to be rejected before a review can begin.

A significant proportion of ANDAs have been refused because of an incomplete English translation or incomplete response to deficiencies that the US FDA found in the filing review.

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More from Biosimilars & Generics

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• By Derrick Gingery

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