Fascination About Abbreviated New Drug Application (ANDA)
If the proper user payment has not been paid out and/or a valid eSTAR or eCopy hasn't been provided, then the FDA will email a Maintain Letter to your 510(k) submitter, generally in seven days of receipt in the 510(k). The submitter then has 180 calendar days in the day in the Hold Letter to completely resolve the problems Along with the person fee