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. 2013 Oct;57(10):4605-7.
doi: 10.1128/AAC.01277-13. Epub 2013 Jul 29.

The FDA reboot of antibiotic development

David M Shlaes  1 , Dan Sahm, Carol Opiela, Brad Spellberg
Affiliations

The FDA reboot of antibiotic development

David M Shlaes et al. Antimicrob Agents Chemother. 2013 Oct.
No abstract available

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Figures

Fig 1
Fig 1
Antimicrobial agents approved by FDA. The number of new antibacterial agents is shown from 1983 to 2012.
See this image and copyright information in PMC

References

    1. Spellberg B, Brass EP, Bradley JS, Lewis R, Shlaes D, Ambrose P, Das A, Boucher HW, Doi Y, Bartlett JG, Bonomo RA, Larosa SP, Talbot GH, Benjamin D, Guidos RJ, Jezek A, Gilbert DN, on behalf of the Infectious Diseases Society of America 2012. White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens. Clin. Infect. Dis. 55:1031–1046 - PMC - PubMed
    1. Rex JH, Eisenstein BI, Alder J, Goldberger M, Meyer R, Dane A, Friedland I, Knirsch C, Sanhai WR, Tomayko J, Lancaster C, Jackson J. 2013. A comprehensive regulatory framework to address the unmet need for new antibacterial treatments. Lancet Infect. Dis. 13:269–275 - PubMed
    1. Shlaes DM, Moellering RC., Jr 2002. The United States Food and Drug Administration and the end of antibiotics. Clin. Infect. Dis. 34:420–422 - PubMed
    1. Projan SJ, Shlaes DM. 2004. Antibacterial drug discovery: is it all downhill from here? Clin. Microbiol. Infect. 10(Suppl 4):18–22 - PubMed
    1. Sharma P, Towse A. 2011. New drugs to tackle antimicrobial resistance: analysis of EU policy options. Office of Health Economics, London, United Kingdom: http://www.ohe.org/publications/article/new-drugs-to-tackle-antimicrobia...

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