Biologics License Application (BLA) - An Overview
If the correct person payment hasn't been compensated and/or a legitimate eSTAR or eCopy has not been provided, then the FDA will e-mail a Hold Letter into the 510(k) submitter, commonly in seven days of receipt on the 510(k). The submitter then has 180 calendar times from the date in the Hold Letter to totally take care of the problems Using the p