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GDF Facility Arrears List (11/10/2014) The following facilities have not satisfied one or more annual facility fee(s) as required under GDF. The facility fee, incurred pursuant to 744B(a)(4)(A)(i),
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What is gdufa arrears list?
The GDUFA arrears list is a list of facilities that are in arrears of their Generic Drug User Fee Amendments (GDUFA) fees.
Who is required to file gdufa arrears list?
Manufacturers and facilities that have not paid their GDUFA fees on time are required to file the arrears list.
How to fill out gdufa arrears list?
The GDUFA arrears list can be filled out online through the FDA's electronic submission system.
What is the purpose of gdufa arrears list?
The purpose of the GDUFA arrears list is to track and collect unpaid GDUFA fees from manufacturers and facilities.
What information must be reported on gdufa arrears list?
The GDUFA arrears list must include the facility name, address, contact information, and the amount owed in GDUFA fees.
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