GDUFA adds a new requirement to FDA’s existing refuse to receive policy with
respect to payment of fees and the time of receipt of an ANDA.
• Failure to pay an ANDA fee within 20 calendar days of the applicable due
date will result in the ANDA not being received.
• Failure to pay the fee for a DMF referenced in the ANDA within 20 calendar
days of the date that FDA provides notification of that failure will result in the
ANDA not being received.
• Failure to pay a facility fee already owed for any facility referenced in the
ANDA within 20 calendar days of the date that FDA provides notification of
that failure will result in the ANDA not being received.
• If an application is substantially complete except for failure to pay the ANDA
fee, or the failure to pay the facility fee within 20 days of notification, the
application will be deemed received as of the date the fee is paid.