Theranos, a company developing new blood-testing technologies and one of the most-talked-about medical technology companies, has recently come under scrutiny. In the midst of news reports that the company’s technology is not what it seems, the FDA posted documents related to a September inspection of Theranos. Professor Patricia Zettler talked with BuzzFeedNews in their article “Here’s What Troubled the FDA When It Inspected Theranos This Summer,” about the significance of those documents and their content, noting that, while the documents are only preliminary indications of any agency determinations, they do raise some questions about the technology.
Patricia J. Zettler is an associate professor at Georgia State University College of Law and a member of the Center for Law, Health & Society. She was a former attorney with the Food and Drug Administration. Zettler’s research focuses on the regulation of medicine, biotechnology, and biomedical research, as well as food and drug policy.