Entries by admin_fidj

Medical Device Manufacturers Seek Quick Approval Overseas

Recently, medical device manufacturers have been shifting their operations overseas in an effort to speed up the approval process. More relaxed regulatory oversight abroad has led some of these companies to make the move to Europe, Asia, and Latin America.

FDA Announces Availability of “Medical Device Innovation Initiative” Report for Public Comment

The U.S. Food and Drug Administration’s (FDA) announced in the Federal Register on February 9, 2011 that its report entitled “Medical Device Innovation Initiative” is available for public comment. This report proposes potential actions to be taken by the FDA’s Center for Devices and Radiological Health (CDRH) to facility the development, assessment, and regulator review of innovative medical devices.

FDA Releases Criteria For Criminal Prosecution Under Park Doctrine

The FDA has released “criteria” it developed for consideration of which cases would be appropriate for misdemeanor criminal prosecution under the Park Doctrine, named after a Supreme Court case called United States v. Park, 421 U.S. 658 (1975).

Swiss Government invokes Mutual Legal Assistance Treaty in fraud investigation of Miami businessman

Recently, the Swiss government, pursuant to a seldom used Mutual Legal Assistance Treaty, (“MLAT”) have requested that the United States Attorneys’ Office in Miami issue subpoenas in regard to a pending Swiss criminal investigation of a Miami businessman suspected of defrauding lenders in Switzerland of over $220 million. The Swiss government alleges that the Miami businessman and others created false financial statements showing that their company was in far better financial shape than was the reality.