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Results: 1-10 of 130

Establishment registration: FDA's new importer disclosure policy burdens foreign establishments
  • Hodgson Russ LLP
  • USA
  • October 24 2012

A foreign establishment cannot register with the FDA for the fiscal year 2013 without disclosing the names, addresses, and phone numbers of “all known importers” of its device in the United States


Mobile apps: the FDA is on its path of enforcement actions
  • Hodgson Russ LLP
  • USA
  • July 24 2013

Mobile health care is one of the most booming industries worldwide, with a strong potential for growth and an excellent financial prognosis. No


Mobile apps: the FDA publishes its final guidance on regulating mobile medical apps
  • Hodgson Russ LLP
  • Canada, USA
  • October 4 2013

Canadian mobile medical app developers will be interested in the FDA's recent guidance on the regulation mobile medical apps in the United States. On


Par pharmaceutical agrees to pay $45M to resolve liability
  • Hodgson Russ LLP
  • USA
  • March 6 2013

According to the Justice Department, Par Pharmaceutical Companies Inc. recently pleaded guilty and agreed to pay $45 million to resolve its liability


Industry reacts to FDA proposed revisions to acceptance of data from clinical studies for medical devices
  • Hodgson Russ LLP
  • USA
  • July 18 2013

On February 25, 2013, the Food And Drug Administration (FDA) issued proposed rules to amend its regulations on acceptance of data from clinical


IRS now accepting applications for $1 billion therapeutic discovery credit program window closes July 21, 2010
  • Hodgson Russ LLP
  • USA
  • June 23 2010

The IRS is now accepting applications for the $1 billion pool of funds earmarked by the health care reform bill (the Patient Protection and Affordable Care Act of 2010) for small and mid-size biotechnology companies to provide needed funding to support critical research and development programs under the qualifying therapeutic discovery tax credit program


Full-time medical residents subject to FICA
  • Hodgson Russ LLP
  • USA
  • February 11 2011

The US Supreme Court recently affirmed a decision of the Court of Appeals for Eighth Circuit upholding the IRS's position that remuneration paid to medical residents working full-time is subject to FICA tax


New grandfathered plan regulations permit insurance contract changes
  • Hodgson Russ LLP
  • USA
  • February 11 2011

Under the Affordable Care Act, group health plans are required to comply with a number of new insurance market reform requirements


Teleradiology ghost reading could present False Claims Act issues
  • Hodgson Russ LLP
  • USA
  • July 11 2011

Teleradiology is becoming more and more common


FDA and CMS announce intention to collaborate in two major areas
  • Hodgson Russ LLP
  • USA
  • October 6 2010

All companies within the health care industry should be aware of two recent developments in the area of medical device approval and federal health care program reimbursement