Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Community,

I have been working since a few months ago in Regulatory Affairs and, to my surprise, I have realized that the company paid for GDUFA fee  in October 2017 ( FY 2018) much more than the amount established by the FDA.
Someone knows  if I can claim after ten months of having made the payment?or what can I do?.

​The FDA's website has some info about payments, and will likely have more info on getting arrears.
Generic Drug User Fee Amendments

------------------------------
Deric Glissmeyer
Regional Director
MasterControl, Inc.

Salt Lake City UT
United States
------------------------------

Original Message:
Sent: 08-Aug-2018 08:50
From: Anonymous Member
Subject: Payment of GDUFA fee

This message was posted by a user wishing to remain anonymous

Dear Community,

I have been working since a few months ago in Regulatory Affairs and, to my surprise, I have realized that the company paid for GDUFA fee  in October 2017 ( FY 2018) much more than the amount established by the FDA.
Someone knows  if I can claim after ten months of having made the payment?or what can I do?.

Please click on the link below for more information and direction.



FDA User Fees Help

Fda		remove preview
FDA User Fees Help FDA's review of a generic drug submission cannot begin until all applicable user fee obligations have been satisfied. A completed GDUFA Cover Sheet provides the necessary information to determine the total user fee amount required and to help the agency track payments. View this on Fda >

------------------------------
Gaurang Bhavsar, MS, RAC
Manager, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA
------------------------------

Original Message:
Sent: 08-Aug-2018 08:50
From: Anonymous Member
Subject: Payment of GDUFA fee

This message was posted by a user wishing to remain anonymous

Dear Community,

I have been working since a few months ago in Regulatory Affairs and, to my surprise, I have realized that the company paid for GDUFA fee  in October 2017 ( FY 2018) much more than the amount established by the FDA.
Someone knows  if I can claim after ten months of having made the payment?or what can I do?.

This message was posted by a user wishing to remain anonymous


Dear Colleague,

Since this discussion is on DMF, I would like to know if there is/are additional fee(s) (on top of user fee) when you amend/update the information on an existing Drug Master File.

Thank you very much.
Original Message:
Sent: 09-Aug-2018 16:02
From: Gaurang Bhavsar
Subject: Payment of GDUFA fee


Please click on the link below for more information and direction.



FDA User Fees Help

Fda		remove preview
FDA User Fees Help FDA's review of a generic drug submission cannot begin until all applicable user fee obligations have been satisfied. A completed GDUFA Cover Sheet provides the necessary information to determine the total user fee amount required and to help the agency track payments. View this on Fda >

------------------------------
Gaurang Bhavsar, MS, RAC
Manager, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA

Original Message:
Sent: 08-Aug-2018 08:50
From: Anonymous Member
Subject: Payment of GDUFA fee

This message was posted by a user wishing to remain anonymous

Dear Community,

I have been working since a few months ago in Regulatory Affairs and, to my surprise, I have realized that the company paid for GDUFA fee  in October 2017 ( FY 2018) much more than the amount established by the FDA.
Someone knows  if I can claim after ten months of having made the payment?or what can I do?.

This message was posted by a user wishing to remain anonymous

I will take your advice. Thanks a lot.
Original Message:
Sent: 09-Aug-2018 16:02
From: Gaurang Bhavsar
Subject: Payment of GDUFA fee


Please click on the link below for more information and direction.



FDA User Fees Help

Fda		remove preview
FDA User Fees Help FDA's review of a generic drug submission cannot begin until all applicable user fee obligations have been satisfied. A completed GDUFA Cover Sheet provides the necessary information to determine the total user fee amount required and to help the agency track payments. View this on Fda >

------------------------------
Gaurang Bhavsar, MS, RAC
Manager, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA

Original Message:
Sent: 08-Aug-2018 08:50
From: Anonymous Member
Subject: Payment of GDUFA fee

This message was posted by a user wishing to remain anonymous

Dear Community,

I have been working since a few months ago in Regulatory Affairs and, to my surprise, I have realized that the company paid for GDUFA fee  in October 2017 ( FY 2018) much more than the amount established by the FDA.
Someone knows  if I can claim after ten months of having made the payment?or what can I do?.

I had a similar experience a few years back when I took over handling User Fees at my company. This was for drugs so the fees were for Product and Establishment Fees back then (not GDUFA).  FDA had miscalculated the Establishment Fees and overcharged us.  Unfortunately this was not discovered until after the deadline for filing a refund request (I believe it was 6 months) so we were not eligible for a refund.  Lesson learned - don't accept that FDA's calculations are always correct. I've found the people at the User Fee office to be quite friendly and responsive to both emails and phone calls.

------------------------------
Tom
Chicago
------------------------------

Original Message:
Sent: 08-Aug-2018 08:50
From: Anonymous Member
Subject: Payment of GDUFA fee

This message was posted by a user wishing to remain anonymous

Dear Community,

I have been working since a few months ago in Regulatory Affairs and, to my surprise, I have realized that the company paid for GDUFA fee  in October 2017 ( FY 2018) much more than the amount established by the FDA.
Someone knows  if I can claim after ten months of having made the payment?or what can I do?.