Google Answers: Amount of data that is presented to FDA to obtain drug approval

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Q: Amount of data that is presented to FDA to obtain drug approval ( No Answer, 1 Comment )

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Subject: Amount of data that is presented to FDA to obtain drug approval
Category: Health > Medicine
Asked by: solars-ga
List Price: $5.00

Posted: 28 Feb 2006 14:41 PST
Expires: 30 Mar 2006 14:41 PST
Question ID: 702066

Average number (or a reliable number in a few cases) of papers
(sheets of paper with data, not articles) a manufacturer has to submit
to the FDA in order to get drug approval. I believe this number runs
into the hundreds of thousands. I need a source and number.

I dont need many sources for each question. As long as there are one
or two which provide the answer and are reliable, that is sufficient

Answer

There is no answer at this time.

Comments

Subject: Re: Amount of data that is presented to FDA to obtain drug approval
From: dr_bob-ga on 06 Mar 2006 19:18 PST

Depends on the indication.  Your numbers are correct.  Usually the
entire NDA filing is shipped by truck(s).

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