Answer

 

If a fee is not paid, the submission “shall be considered incomplete and shall not be accepted for filing” until the fee is paid in full. FDA will not begin its review of a submission until the fee for that submission is paid and all fees for previous submissions have been paid. If a fee is not paid within 30 days after it is due, the fee may be treated as a claim of the U.S. Government.


Last revised: March 28, 2007