Re: Looking for information re FDA submissions

[John Posada <jposada01 -at- yahoo -dot- com>]

Attached is a link to an example of an NDA on the web.
It leads to an exe containing a zip of numerous
documents.

http://www.fda.gov/cder/guidance/NDA_Example.htm

I hope you know what you are getting into. An new drug
submission isn't a document. it is a collection of
documents, sometimes numbering into the millions of
pages.

Go to http://www.fda.gov/cder/guidance/

This is a web page containing a large number of
"guidance" documents from the Center for Drug
Evaluation and Research.

Man, good luck and I hope that payment on the farm is
still a number of years away!


--- Win Day <winday -at- home -dot- com> wrote:
> Has anyone here ever written an FDA submission for a
> medical device?
> 


=====
John Posada, Merck Research Laboratories
Sr Technical Writer, WinHelp and html
(work) john_posada -at- merck -dot- com - 732-594-0873
(pers) jposada01 -at- yahoo -dot- com - 732-291-7811
"When in trouble, when in doubt, run in circles, scream and shout."
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