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Drug Evaluation & Research

CDERNEW-TEXT 8/28 - 29/2007

Wednesday, August 29, 2007

August 29, 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)

New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Saizen (somatropin [rDNA origin]) Injection, EMD Serono, Labeling
Revision

Serostim (somatropin [rDNA origin]) Injection, EMD Serono, Labeling
Revision

Sumatriptan Succinate Tablets, Watson Labs, Tentative Approval

WelChol (colesevelam HCl) Tablets, Daiichi Sankyo, Labeling Revision

August 28, 2007

Office of Nonprescription Products: Rulemaking History for
Nonprescription Products
http://www.fda.gov/cder/otcmonographs/rulemaking_index.htm

(updated)

Guidance for Industry: Pharmacogenomic Data Submissions - Companion
Guidance http://www.fda.gov/cder/guidance/7735dft.pdf

PDF
http://www.fda.gov/graphics/pdf.gif

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posted by Mags @ 4:09 PM,

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