An Unbiased View of Abbreviated New Drug Application (ANDA)
If the correct user fee hasn't been compensated and/or a legitimate eSTAR or eCopy has not been presented, then the FDA will electronic mail a Hold Letter to your 510(k) submitter, normally in just seven days of receipt on the 510(k). The submitter then has one hundred eighty calendar days through the date of your Hold Letter to totally solve the p