An Unbiased View of Abbreviated New Drug Application (ANDA)
If the appropriate consumer payment hasn't been paid out and/or a valid eSTAR or eCopy hasn't been provided, then the FDA will electronic mail a Keep Letter towards the 510(k) submitter, typically inside of seven days of receipt of the 510(k). The submitter then has one hundred eighty calendar days within the date with the Maintain Letter to totall