Search Results for Theranos

Showing 1 – 6

Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test By Zachary Brennan - Published 18 April 2017

As part of an agreement reached with Arizona attorney general Mark Brnovich, the medical device startup Theranos on Tuesday agreed to pay $4.65 million for about 1.5 million blood tests sold to more than 175,000 Arizonans.

Categories: News, US, Compliance, Crisis management, In vitro diagnostics, Medical Devices

Tags: Theranos, blood test, Arizona, CMS

FDA Form 483: Theranos Initiated Trials Without IRB Approval By Zachary Brennan - Published 09 September 2016

The US Food and Drug Administration (FDA) on Friday released a Form 483 issued 18 August to blood testing startup Theranos, citing the company for allowing patients to consent to sample collection in two Zika-related trials without approval of an institutional review board (IRB).

Categories: News, US, FDA, Ethics, Government affairs, In vitro diagnostics, Medical Devices

Tags: Theranos, Elizabeth Holmes, Zika, Form 483

Democrats Tell FDA, CMS to Hand Over Theranos Data By Michael Mezher - Published 28 July 2016

A group of high-ranking Democrats sent letters to the heads of the US Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) this week asking them to turn over data from their investigations of blood testing startup Theranos.

Categories: News, US, FDA, Government affairs, In vitro diagnostics

Tags: Theranos

Regulatory Recon: Juno Halts Trial After 3 Deaths; Theranos CEO Banned From Running Lab for 2 Years (8 July 2016) By Zachary Brennan - Published 08 July 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Canada, Europe, US, CFDA, EC, EMA, FDA, Health Canada, PMDA, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance, Research and development

Tags: Juno, Theranos, Califf, FDA, Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Democrats Call on Theranos CEO to Testify About Regulatory Shortcomings, Inaccurate Test Results By Michael Mezher - Published 06 July 2016

A group of high-ranking House Democrats have launched an inquiry into blood testing startup Theranos over its adherence to clinical laboratory testing standards.

Categories: News, US, FDA, Government affairs, In vitro diagnostics

Tags: Theranos, CMS, Test Results, Edison

FDA Details Theranos Deficiencies in Two Form 483s By Zachary Brennan - Published 27 October 2015

The heavily-redacted Form 483s released by the US Food and Drug Administration (FDA) on Tuesday for the blood testing company Theranos include 14 observations, with several on device design, classification and on how the company deals with complaints.

Categories: News, US, FDA, Blood, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: Theranos, Elizabeth Holmes, FDA, Form 483