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Jeremy Halpern
  • Nutter McClennen & Fish LLP

Executives and medical device company criminally indicted for off-label use and false statements during an inspection
  • Baker & Hostetler LLP
  • USA
  • June 25 2009

The U.S. Attorney’s Office for the Eastern District of Pennsylvania indicted medical device manufacturer Norian and four of its executives for the alleged improper testing, marketing and sale of two of its bone cement devices and for false statements made by company personnel during a regulatory inspection of the facility.


DOJ Prosecutes Former Healthcare Executives for Individual Culpability
  • FisherBroyles LLP
  • USA
  • May 26 2016

Since last September when Deputy Attorney General Sally Quillian Yates issued a memo to federal attorneys nationwide, directing the aggressive


Consumer protection: Commission publishes 2006 annual report on dangerous consumer products
  • McDermott Will & Emery
  • European Union
  • April 27 2007

Article 12 of Directive 200195EC on general product safety imposes an obligation on Member States to notify the European Commission whenever they adopt restrictive measures in relation to the marketing or use of products within their territory.


Risk mitigation strategies for manufacturers of nanomaterials
  • Reed Smith LLP
  • USA
  • September 1 2007

Despite regulatory uncertainties and the lack of safety data, companies are rushing nanomaterials to market in a wide variety of FDA-regulated product categories.


James W. Brenner
  • Porzio Bromberg & Newman PC

FDA scrutinizes mobile medical app intriguing letter to app developer precedes expected release of final guidance
  • Ropes & Gray LLP
  • USA
  • May 31 2013

On May 21, 2013, the Food and Drug Administration ("FDA") issued an "It Has Come to Our Attention Letter" to Biosense Technologies Private Limited


Megan E. Robertson
  • Epstein Becker Green

FDA Continues Its Press On Medical Device Cybersecurity
  • Reed Smith LLP
  • USA
  • October 12 2018

Did you know that October is National Cybersecurity Awareness Month? Neither did we, until we started poking around the FDA’s recent press release


Areta Kupchyk
  • Reed Smith LLP