The U.S. Food and Drug Administration (FDA) will announce new rules for reviewing the first copies of biologic drugs, also known as “biosimilars.” According to FDA Commissioner Margaret Hamburg, these […]
On February 9, 2011, the Fifth Circuit Court of Appeals issued an opinion in a consolidated appeal in Daniel Burks, as Tax Matters Partner for Key Harbor Investment Partners v. United States.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-02-21 10:02:502025-12-09 13:57:29Fifth Circuit Rules against the United States in basis overstatement case – causing further rift between the Circuits in Son of BOSS cases
On February 16, 2011, the Financial Crimes Enforcement Network (FinCEN) issued a guidance document (available here) “to remind U.S. financial institutions of their requirement to apply enhanced scrutiny for private […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-02-17 09:38:582025-12-09 13:56:57FinCEN Issues Guidance To Financial Institutions On Recent Events In Egypt
On February 8, 2011, the IRS issued an announcement entitled: “Second Special Voluntary Disclosure Initiative Opens; Those Hiding Assets Offshore Face Aug. 31 Deadline” via IR-2001-14, available here.
On January 26, 2011, Florida’s Fourth DCA entered its opinion in Baker v. Storfer, and ruled that the definition of “salary or wages” as used in Florida Statute section 77.035 includes “commissions.” The matter was a case of first impression in the State of Florida.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-02-15 12:48:442025-12-09 13:56:29Florida’s Fourth District Court of Appeal Expands Definition of “Salaries or Wages” to Include Commissions
The National Oceanic and Atmospheric Administration (NOAA) recently released a draft policy document detailing its intentions to increase aquaculture domestically. The cultivation of sea-life in selected environments, a process known […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-02-11 16:43:362025-12-09 13:56:17NOAA Seeks to Expand Aquaculture to Increase Consumption of Domestic Seafood
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.
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.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-02-10 16:00:282025-12-09 13:55:27FDA Announces Availability of “Medical Device Innovation Initiative” Report for Public Comment
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).
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-02-08 14:19:262025-12-09 13:55:10FDA Releases Criteria For Criminal Prosecution Under Park Doctrine
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.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-02-07 15:22:492014-11-10 18:21:13Swiss Government invokes Mutual Legal Assistance Treaty in fraud investigation of Miami businessman
FDA to Unveil Rules for Reviewing Biosimilars “Very Soon”
The U.S. Food and Drug Administration (FDA) will announce new rules for reviewing the first copies of biologic drugs, also known as “biosimilars.” According to FDA Commissioner Margaret Hamburg, these […]
Fifth Circuit Rules against the United States in basis overstatement case – causing further rift between the Circuits in Son of BOSS cases
On February 9, 2011, the Fifth Circuit Court of Appeals issued an opinion in a consolidated appeal in Daniel Burks, as Tax Matters Partner for Key Harbor Investment Partners v. United States.
FinCEN Issues Guidance To Financial Institutions On Recent Events In Egypt
On February 16, 2011, the Financial Crimes Enforcement Network (FinCEN) issued a guidance document (available here) “to remind U.S. financial institutions of their requirement to apply enhanced scrutiny for private […]
IRS Announces Second Special Offshore Voluntary Disclosure Initiative (OVDI)
On February 8, 2011, the IRS issued an announcement entitled: “Second Special Voluntary Disclosure Initiative Opens; Those Hiding Assets Offshore Face Aug. 31 Deadline” via IR-2001-14, available here.
Florida’s Fourth District Court of Appeal Expands Definition of “Salaries or Wages” to Include Commissions
On January 26, 2011, Florida’s Fourth DCA entered its opinion in Baker v. Storfer, and ruled that the definition of “salary or wages” as used in Florida Statute section 77.035 includes “commissions.” The matter was a case of first impression in the State of Florida.
NOAA Seeks to Expand Aquaculture to Increase Consumption of Domestic Seafood
The National Oceanic and Atmospheric Administration (NOAA) recently released a draft policy document detailing its intentions to increase aquaculture domestically. The cultivation of sea-life in selected environments, a process known […]
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.