Theranos Experience Exposes Weaknesses in FDA Regulatory Discretion

Clin Pharmacol Drug Dev. 2017 Sep;6(5):433-438. doi: 10.1002/cpdd.374. Epub 2017 Jul 24.

Authors

Rohan Jotwani¹, Marcia Boumil², Deeb Salem³, Madeline Wetterhahn⁴, Paul Beninger²

Affiliations

¹ Department of Anesthesiology, NewYork-Presbyterian/Weill Cornell Medical Center, New York, NY.
² Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA.
³ Department of Medicine, Tufts Medical Center and Tufts University School of Medicine, Boston, MA, USA.
⁴ Tufts University School of Medicine, Boston, MA, USA.

PMID: 28741304
DOI: 10.1002/cpdd.374

No abstract available

MeSH terms

Clinical Laboratory Techniques*
Diagnostic Test Approval*
Government Regulation
Manufacturing Industry
United States
United States Food and Drug Administration / legislation & jurisprudence*