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Editorial
. 2018 Aug 28;56(9):1395-1396.
doi: 10.1515/cclm-2018-0392.

The Theranos saga and the consequences

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Free article
Editorial

The Theranos saga and the consequences

Karl J Lackner et al. Clin Chem Lab Med. .
Free article
No abstract available

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References

    1. Fiala C, Diamandis EP. The meteoric rise and dramatic fall of Theranos: lessons learned for the diagnostic industry. Clin Chem Lab Med 2018;56:1443–6.
    1. US Securities and Exchange Commission. Theranos, CEO Holmes, and former president Balwani charged with massive fraud. Press release 2018-41; https://www.sec.gov/news/press-release/2018-41#. Accessed: 16 Apr 2018.
    1. FDA – Overview of IVD regulations. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegula.... Accessed: 16 Apr 2018.
    1. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Off J Eur Union 2017;60:L117.
    1. Jotwani R, Boumil M, Salem D, Wetterhahn M, Beninger P. Theranos experience exposes weaknesses in FDA regulatory discretion. Clin Pharmacol Drug Dev 2017;6:433–8.

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