Understanding the regulatory hurdles for antibacterial drug development in the post-Ketek world-Reference-Cited by-同舟云学术

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Understanding the regulatory hurdles for antibacterial drug development in the post-Ketek world

Published:2011-12 Issue:1 Volume:1241 Page:153-161
ISSN:0077-8923
Container-title:Annals of the New York Academy of Sciences
language:en
Short-container-title:

Author:

Echols Roger M.

Publisher

Wiley

Subject

History and Philosophy of Science,General Biochemistry, Genetics and Molecular Biology,General Neuroscience

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/j.1749-6632.2011.06300.x/fullpdf

Reference56 articles.

1. http://www.fda.gov/ohrms/dockets/ac/cder06.html#AntiInfective

2. Edelberg , H.K. 2006 http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4266s1-02-03-Ketek-Edelberg.pdf

3. Telithromycin and the FDA: implications for the future;Shlaes;The Lancet,2008

4. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070939

5. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070935

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