Rumored Buzz on Abbreviated New Drug Application (ANDA)
If the proper person charge has not been paid out and/or a sound eSTAR or eCopy hasn't been offered, then the FDA will e mail a Maintain Letter to the 510(k) submitter, normally within 7 days of receipt from the 510(k). The submitter then has a hundred and eighty calendar times in the day from the Maintain Letter to totally take care of the problem