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Drug Evaluation & Research

CDERNEW-TEXT 10/12/2007

Monday, October 15, 2007

October 12, 2007

Dissolution Methods Database
http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm
(updated)

Drug Master Files http://www.fda.gov/cder/dmf/index.htm

(updated)

Drug Shortage: Drug to be Discontinued; Sporanox
http://www.fda.gov/cder/drug/shortages/default.htm#Sporanox

FDA issues an FDA Alert and Healthcare Professional Sheet on 2
micro-bubble contrast agents, Definity and Optison
http://www.fda.gov/cder/drug/infopage/microbubble/default.htm

Guidance for Industry: Antibacterial Drug Products: Use of
Noninferiority Studies to Support Approval [PDF
http://www.fda.gov/cder/guidance/7884dft.pdf ] or [HTML
http://www.fda.gov/cder/guidance/7884dft.htm ]

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

HYCAMTIN (topotecan), GlaxoSmithKline, Approval

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posted by Mags @ 3:33 AM,

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