Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi everyone,

I was hoping to have some help with the FDA PDUFA VI Fees. What are the fees for submitting a research and commercial IND to the FDA? Is there a source where fee information for IND applications is available?

FDA User Fee Table FY2021
Prescription Drug User Fee Act (PDUFA VI)	FY2021	FY2020	Change
Applications:
Requiring clinical data	$2,875,842	$2,942,965	-$67,123
Not requiring clinical data	$1,437,921	$1,471,483	-$33,562
Program fee	$336,432	$325,424	$11,008

Thank you in advance for your help!

There is no fee for an IND application.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Scynexis, Inc.
New York NY
United States
------------------------------

Original Message:
Sent: 12-May-2021 11:05
From: Anonymous Member
Subject: IND application fees

This message was posted by a user wishing to remain anonymous

Hi everyone,

I was hoping to have some help with the FDA PDUFA VI Fees. What are the fees for submitting a research and commercial IND to the FDA? Is there a source where fee information for IND applications is available?

FDA User Fee Table FY2021
Prescription Drug User Fee Act (PDUFA VI)	FY2021	FY2020	Change
Applications:
Requiring clinical data	$2,875,842	$2,942,965	-$67,123
Not requiring clinical data	$1,437,921	$1,471,483	-$33,562
Program fee	$336,432	$325,424	$11,008

Thank you in advance for your help!

This message was posted by a user wishing to remain anonymous

No fee for INDs
Original Message:
Sent: 12-May-2021 11:05
From: Anonymous Member
Subject: IND application fees

This message was posted by a user wishing to remain anonymous

Hi everyone,

I was hoping to have some help with the FDA PDUFA VI Fees. What are the fees for submitting a research and commercial IND to the FDA? Is there a source where fee information for IND applications is available?

FDA User Fee Table FY2021
Prescription Drug User Fee Act (PDUFA VI)	FY2021	FY2020	Change
Applications:
Requiring clinical data	$2,875,842	$2,942,965	-$67,123
Not requiring clinical data	$1,437,921	$1,471,483	-$33,562
Program fee	$336,432	$325,424	$11,008

Thank you in advance for your help!

This message was posted by a user wishing to remain anonymous

None
Original Message:
Sent: 12-May-2021 11:05
From: Anonymous Member
Subject: IND application fees

This message was posted by a user wishing to remain anonymous

Hi everyone,

I was hoping to have some help with the FDA PDUFA VI Fees. What are the fees for submitting a research and commercial IND to the FDA? Is there a source where fee information for IND applications is available?

FDA User Fee Table FY2021
Prescription Drug User Fee Act (PDUFA VI)	FY2021	FY2020	Change
Applications:
Requiring clinical data	$2,875,842	$2,942,965	-$67,123
Not requiring clinical data	$1,437,921	$1,471,483	-$33,562
Program fee	$336,432	$325,424	$11,008

Thank you in advance for your help!

Hello,

There are no fees associated with an IND.  When the fee schedule was put in place, INDs were purposely designed without a fee.  Many felt that a fee on INDs would stifle innovation.  Before filing an IND, you should really consider having a pre-IND meeting with the agency.  It provides a good opportunity to discuss clinical development and gives the agency notice that a new IND is soon to be filed.


------------------------------
Stephen Westover
Director of Regulatory Affairs
Pittsburgh PA
United States
------------------------------

Original Message:
Sent: 12-May-2021 11:05
From: Anonymous Member
Subject: IND application fees

This message was posted by a user wishing to remain anonymous

Hi everyone,

I was hoping to have some help with the FDA PDUFA VI Fees. What are the fees for submitting a research and commercial IND to the FDA? Is there a source where fee information for IND applications is available?

FDA User Fee Table FY2021
Prescription Drug User Fee Act (PDUFA VI)	FY2021	FY2020	Change
Applications:
Requiring clinical data	$2,875,842	$2,942,965	-$67,123
Not requiring clinical data	$1,437,921	$1,471,483	-$33,562
Program fee	$336,432	$325,424	$11,008

Thank you in advance for your help!

No fee for IND

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
------------------------------

Original Message:
Sent: 12-May-2021 11:05
From: Anonymous Member
Subject: IND application fees

This message was posted by a user wishing to remain anonymous

Hi everyone,

I was hoping to have some help with the FDA PDUFA VI Fees. What are the fees for submitting a research and commercial IND to the FDA? Is there a source where fee information for IND applications is available?

FDA User Fee Table FY2021
Prescription Drug User Fee Act (PDUFA VI)	FY2021	FY2020	Change
Applications:
Requiring clinical data	$2,875,842	$2,942,965	-$67,123
Not requiring clinical data	$1,437,921	$1,471,483	-$33,562
Program fee	$336,432	$325,424	$11,008

Thank you in advance for your help!

There are no fees for filing an IND.  The table of fees you included in your email are for filing an NDA, supplemental NDA and annual program fees (once you have a product approved).

------------------------------
Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
------------------------------

Original Message:
Sent: 12-May-2021 11:05
From: Anonymous Member
Subject: IND application fees

This message was posted by a user wishing to remain anonymous

Hi everyone,

I was hoping to have some help with the FDA PDUFA VI Fees. What are the fees for submitting a research and commercial IND to the FDA? Is there a source where fee information for IND applications is available?

FDA User Fee Table FY2021
Prescription Drug User Fee Act (PDUFA VI)	FY2021	FY2020	Change
Applications:
Requiring clinical data	$2,875,842	$2,942,965	-$67,123
Not requiring clinical data	$1,437,921	$1,471,483	-$33,562
Program fee	$336,432	$325,424	$11,008

Thank you in advance for your help!