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Q: FDA Filings (NDA or IND) ( Answered,   0 Comments )
Subject: FDA Filings (NDA or IND)
Category: Business and Money
Asked by: cgray-ga
List Price: $50.00
Posted: 28 Oct 2004 04:18 PDT
Expires: 27 Nov 2004 03:18 PST
Question ID: 421139
I want to know the annual number of FDA filings (NDA/IND) and the cost
associated with the filings?

I would also like to know the source(s) of the answer.

Request for Question Clarification by pafalafa-ga on 28 Oct 2004 04:56 PDT
Hello cgray-ga,

In 2003, submissions to FDA included:

105 NDA's
  8 BLA's
 25 NME's

I can detail the costs, in terms of submission fees, associated with
these applications.

Would that information meet your needs?  Let me know.


Clarification of Question by cgray-ga on 28 Oct 2004 09:11 PDT
This is the information I'm interested in... detailing the cost and
citing the source would meet my requirements.

Thank you,
Subject: Re: FDA Filings (NDA or IND)
Answered By: pafalafa-ga on 28 Oct 2004 12:40 PDT

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 

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 ]
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