Thanks for your feedback.
The FDA is required by the 1992 Prescription Drug User Fee Act (PDUFA)
and subsequent renewals/amendments of the law to collect fees from
many of companies that have submitted applications for review of a new
drug or a related product.
You can find a great deal of information about PDUFA at FDA's page
devoted to "Prescription Drug User Fees" at:
As part of the requirements of PDUFA, FDA has to submit several annual
reports to Congress on both the performance and the financial aspects
of the PDUFA programs, and it is these reports that contain the
detailed information you're looking for.
A collection of the reports can be found here:
The most recent Performance report for -- FY 2003 Performance Report
to Congress -- can be found at these two links:
The reports are a bit awkward to access, as each section is separate
URL. However, the specific information that you're looking for can be
found at the following links:
The section on "Workload" in the Performance report details the number
of original submissions filed in FY03 as:
NDA's -- 105
BLA's -- 8
NME's -- 25
The Financial Report for the same year is here:
FY 2003 Financial Report to Congress
and details the fees received in the table, "FOOD AND DRUG ADMINISTRATION
STATEMENT OF USER FEE REVENUES BY FEE SOURCE", as:
Application Fees-- $65,959,471
Establishment Fees --$74,399,534
Product Fees --$69,012,000
As I'm sure you're aware, these are complex programs with an abundance
of acronyms, categories, exemptions, and the like. I hope I've given
you exactly the information you were looking for.
Before rating this answer, though, please let me know if you need any
additional information about anything I've presented here. Just post
a Request for Clarification, and I'll be happy to assist you further.
All the best,
search strategy -- Google search on [nda 2003 site:fda.gov ]