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Drug Evaluation & Research

CDERNEW-TEXT 10/24/2007

Thursday, October 25, 2007

October 24, 2007

CDER Organization Charts [HTML http://www.fda.gov/cder/cderorg.htm ]
[PDF http://www.fda.gov/cder/cderorg/cder-all.pdf ] (updated)

Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm

(updated)

FDA and Cephalon notify healthcare professionals of updates to the
Warnings section of the prescribing information for Provigil (modafinil)
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Provigil

Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical
Evaluation [PDF http://www.fda.gov/cder/guidance/7507dft.pdf ] or [HTML
http://www.fda.gov/cder/guidance/7507dft.htm ]

Warning Letter: BMIS Inspection (Warning Letter) Sanofi-Aventis U.S.
http://www.fda.gov/cder/warn/warn2007.htm#October

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posted by Mags @ 6:38 AM,

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