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Genentech receives FDA Refuse to File Letter for T-DM1
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08-27-2010, 12:05 PM
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Hopeful
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Join Date: Aug 2006
Posts: 3,380
Re: Genentech receives FDA Refuse to File Letter for T-DM1
FDA Guidance on "Refuse to File":
http://www.fda.gov/downloads/Drugs/G.../UCM080561.pdf
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