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GDUFA and BsUFA User Fees – Time to pay the piper!

FDA’s User Fee Staff provided an overview of the progress and implementation of the first year of GDUFA II and BsUFA II user fees during the afternoon session of the second day of the GRx +Biosims Conference held at Baltimore, MD from September 5-7. The presentation recapped how the user fee structure for GDUFA II an BsUFA II changed, provided an update on the program fee implementation and useful reminders regarding user fee-related deadlines.

For GDUFA II user fees, important dates to remember:

April 1st – Deadline to submit ANDA withdrawals for the upcoming fiscal year

Early August – FDA publishes the user fees for the upcoming Fiscal Year in the Federal Register

Early September – Web posting with program tiers

October 1st – Annual payment due date

Also noteworthy is that the first list of all parent company portfolios will be posted in January 2019. Firms are encouraged to review this list and notify FDA of any corrections as soon as possible. The list can be accessed via FDA’s website or the CDER Direct NextGen Portal.

For BsUFA II user fees, important dates to remember are the following:

April – Annual survey sent to biosimilar sponsors

June – Notification of BsUFA fees correspondence to sponsors

August 1st – Deadline to submit request to discontinue participation in the BPD (Biosimilar Product Development) program

Mid to Late August – Annual BPD and Program fee invoices sent

September 30th – Deadline to move approved products to discontinued list

October 1st – Invoice payments due

December – Second invoices sent for fee liable products not invoiced in August

January – Second invoice payments due

It is important that sponsors review the BsUFA list regularly and notify FDA of any discrepancies to insure fees invoiced are correct. The list is available on the BsUFA website.

As the October 1st GDUFA II and BsUFA payment due date approaches, sponsors are encouraged to remit their payments on time. Penalties and interest may be assessed for late payments.