RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test

    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. The deal was forged after Theranos said it ultimately had to void or correct over 830,000 test results, which was about 11% of all results. A day earlier, Theranos announced it would settle with the federal Centers for Medicare & Medicaid Se...
  • Regulatory NewsRegulatory News

    FDA Form 483: Theranos Initiated Trials Without IRB Approval

    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). The one-page FDA report says that the three-day inspection of Theranos' Palo Alto, CA facility in mid-August uncovered evidence that Theranos initiated clinical investigations for two clinical ...
  • Regulatory NewsRegulatory News

    Democrats Tell FDA, CMS to Hand Over Theranos Data

    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. "Given Theranos' disregard for patient safety and its failure to immediately address concerns by federal regulators, we write to request more information about how regulators are working with Theranos to address thes...
  • ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Juno Halts Trial After 3 Deaths Theranos CEO Banned From Running Lab for 2 Years (8 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. In Focus: US Juno Halts Cancer Trial Using Gene-Altered Cells After 3 Deaths ( Forbes ) ( NY Times ) ( WSJ -$) ( Xconomy ) ( Endpoints ) ( Stat ) ( Fierce ) ( TheStreet ) ( Reuters ) ( Scrip -$) ( In the Pipeline ) ( Press ) FDA Approves Genentech’s Xolair (omalizumab) for Allergic Asthma in Children...
  • Regulatory NewsRegulatory News

    Democrats Call on Theranos CEO to Testify About Regulatory Shortcomings, Inaccurate Test Results

    A group of high-ranking House Democrats have launched an inquiry into blood testing startup Theranos over its adherence to clinical laboratory testing standards. Following inspections last year, the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) each cited Theranos for a number of compliance issues. In a letter dated 30 June 2016, Reps. Frank Pallone (D-NJ), Gene Green (D-TX) and Diana DeGette (D-CO) call on Theranos CEO ...
  • Regulatory NewsRegulatory News

    FDA Details Theranos Deficiencies in Two Form 483s

    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. Most recently, the highly-valuated Theranos has come under fire following a Wall Street Journal investigation that raised a number of questions about the accuracy of the company's proprietary blood testing technology and ...