FDA NDA user fees...
FY1993 (10/1/92-9/30/93):
NDA/PLA application fees (per co.)*: $100,000
Supplemental application fees (per co.): $50,000
FY1994 (10/1/93-9/30/94):
NDA/PLA application fees: $150,000
Supplemental application fees: $75,000
FY1995 (10/1/94-9/30/95):
NDA/PLA application fees: $208,000
Supplemental application fees: $104,000
FY1996 (10/1/95-9/30/96):
NDA/PLA application fees: $217,000
Supplemental application fees: $108,000
FY1997 (10/1/96-9/30/97):
NDA/PLA application fees: $233,000
Supplemental application fees: $116,000
No data from '97 to 2002. Then...
fda.gov
Call it a $800,000 CDN, roughly.
Table 3.
------------------------------------------------------------------------
Fee Category Fee rates for FY 2003
------------------------------------------------------------------------
Applications
Requiring clinical data $533,400
Not requiring clinical data $266,700
Supplements requiring clinical data $266,700
Establishments $209,900
Products $32,400
------------------------------------------------------------------------
------------------------------------------------------------------------
FDA can collect user fees only if its congressional appropriation increases are equivalent to those of other arms of government; the user fees will be dedicated to FDA; and small companies (those with fewer than 500 employees) whose first prescription drugs have not yet been approved pay one-half of the normal application fee, and can defer this payment up to one year. Additionally, FDA has the power to waive or defer fees if they threaten to stifle innovation at start-up firms.
Not clear what exemptions a foreign firm like DMX would get - if any.
Even with a 50% discount, DMX will require ~ CDN $400,000, for the WF10 NDA - unless they got it in calendar 2002. Look for a bulge in quarterly R+D. |
