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Elizabeth Orr

Washington, DC
Elizabeth Orr focuses on legal affairs affecting the medical device industry. Before joining Informa in September 2015, she spent three years spent reporting on all things device-related at FDANews. She remains fascinated by the ever-changing master class on technology, government regulations, advances in health care and more that is covering the device industry. Elizabeth’s past employers include DecisionHealth (formerly UCG); the Society of Interventional Radiology; and the Washington Examiner.  A graduate of the College of Journalism at the University of Maryland College Park, she lives in Arlington, Va., with her husband and children.

Latest From Elizabeth Orr

J&J Faces Fraud Claims From Merger With Surgical Robot Firm

Investors in surgical robotics company Auris say Johnson & Johnson failed to support the company per their merger agreement.

Legal Issues Commercial

COVID-19: Newly Authorized Device From OraSure Subsidiary Allows At-Home Collection Of Saliva Samples

The device is among the first that does not require a health care professional to supervise the saliva sample-collection process.

Coronavirus COVID-19 In Vitro Diagnostics

FDA’s Biotin Interference Guidance Finalized

The document recommends testing for blood biotin levels as high as 3500 ng/mL, three times the maximum expected clinical concentration.

Guidance Documents FDA

Merit Medical To Pay $18M To Settle Kickback Case

The US Department of Justice says the company provided advertising assistance and educational grants to health care providers that used its embolization devices.

Commercial Legal Issues

Priority Lane: Guidances On Risky Devices, 510(k) Reform Top FDA’s To-Do List

The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.

Guidance Documents Policy

Device Week, 16 October 2020 – FDA Issues 3 Guidance Docs

On this week’s podcast: The US FDA was busy with draft and final guidance documents this week, issuing three within 24 hours. The docs address disparate device industry concerns, ranging from of-the-moment issues like coronavirus test supplies, to more traditional concerns around device materials testing.

Device Week FDA
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