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Thursday, 05/23/2019 11:46:25 PM

Thursday, May 23, 2019 11:46:25 PM

Post# of 424190
Friday is the last business day before the 60 day deadline.

When will I know that my NDA has been accepted for filing?

You will know within 60 days of submitting your NDA whether it has been accepted for filing (or conversely, if FDA refuses to file your application). If your application is accepted for filing (60 days after submission), then you will receive a 74-day letter, which confirms your action date, confirms standard versus priority review, and identifies any preliminary deficiencies in your application.


https://weinberggroup.com/blog/nda-review-fda-submission/

My understanding is that the 60 day notification and the 74 day letter are usually combined into one.
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