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. 2014 Sep;174(9):1436-7.
doi: 10.1001/jamainternmed.2014.3055.

The potential risks of expedited approval of drugs for acute bacterial infections

James S Floyd  1 , Bruce M Psaty  2
Affiliations

The potential risks of expedited approval of drugs for acute bacterial infections

James S Floyd et al. JAMA Intern Med. 2014 Sep.
No abstract available

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Conflict of interest statement

Conflict of Interest Disclosure: Dr. Psaty reports serving on the data and safety monitoring board for a clinical trial of a cardiovascular device funded by the manufacturer (Zoll LifeCor VEST), which dose not relate to the topic of this article; on the Steering Committee of the Yale Open Data Access Project funded by Johnson & Johnson; and on the FDA Science Board.

References

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    1. Food and Drug Adminsitration. Gudiance for Industry: Expedited Programs for Serious Conditions - Drugs and Biologics. 2013 Jun; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati....
    1. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med. 1996 Oct 1;125(7):605–613. - PubMed
    1. Food and Drug Adminsitration. Guidance for Industry. Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment. 2010 Nov; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati....
    1. Food and Drug Adminsitration. Meeting Materials, November 29, 2012 Meeting of the Anti-Infective Drugs Advisory Committee; http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/A....

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